Sunday, 29 November 2015
Saturday, 28 November 2015
PUNE. Pharmacist / Pharma walk in Interview 30 Nov 2015 to 12 Dec 2015
Pharmacist / Pharma walk in Interview 30 Nov 2015 to 12 Dec 2015
Ace group
0 - 5 Years
10 Vacancies
Pune
1,00,000 - 4,00,000 P.A
Job Description
D.pharma, B.Pharma ,M.Pharma ,Chemical ,Are any degree . Candidate should have knowledge of pharma. with good knowledge of communication skills, Innovate bent of mind, Analytical and Problem solving skills fresher and exp
ACE Company is one of the fastest growing and innovative IT &manufacturing CG Companay firm based out of Pune, India. Address ACE Group 1st floor, sawant park, pune-satara raod, chaitnya nagar, dhanakwdi, pune, maharastra, HR 020-65233331 9689146883
ARTICLE:-- Drug Recalls Details by FDA
Drug Recalls Details by FDA
Recalls are actions
taken by a firm to remove a product from the market. Recalls may be conducted
on a firm's own initiative, by FDA request, or by FDA order under statutory
authority. See Definitions of Market Withdrawals and Class I, II, and III
recalls. All recalls (Class I, II, and III) can be found in the FDA Enforcement
Report.
In July 2011, FDA began
a pilot program to notify people of drug recalls before they are classified.
These unclassified recalls will be published in the Enforcement Report every
Wednesday, and will be listed under the heading, “Human Drug Product Recalls
Pending Classification.” They will be reposted with their classification once
that determination has been made.
Background
and Definitions
Recalls
are actions taken by a firm to remove a product from the market. Recalls may be
conducted on a firm's own initiative, by FDA request, or by FDA order under
statutory authority.
- Class I recall: a situation in which
there is a reasonable probability that the use of or exposure to a
violative product will cause serious adverse health consequences or death.
- Class II recall: a situation in which
use of or exposure to a violative product may cause temporary or medically
reversible adverse health consequences or where the probability of serious
adverse health consequences is remote.
- Class III recall: a situation in which
use of or exposure to a violative product is not likely to cause adverse
health consequences.
- Market withdrawal: occurs when a product
has a minor violation that would not be subject to FDA legal action. The
firm removes the product from the market or corrects the violation. For
example, a product removed from the market due to tampering, without
evidence of manufacturing or distribution problems, would be a market
withdrawal.
- Medical device safety alert: issued in situations
where a medical device may present an unreasonable risk of substantial
harm. In some case, these situations also are considered recalls.
ARTICLE:- How to Become a U.S. Food and Drug Inspector
How
to Become a U.S. Food and Drug Inspector
Reprinted
from: The
Civil Service Magazine, issue of September 6,
1913. Editor's note: this article was published approximately 50 years before
FDA swore in the first female food and drug inspector.
Exceedingly
few people outside of the limited number of employees in the Bureau of
Chemistry, Department of Agriculture, have a substantially correct conception
of the organization, work, duties and efficiency of the national corps of
United States Food and Drug Inspectors--the official guardians of each
citizen's "department of interior." Even less are aware of the fact
that these positions are more remunerative, more dignified, more interesting,
and more instructive than almost any other in the federal civil service field.
Among
the numerous and unusual advantages offered, may be mentioned the following: A
big initial salary with fine prospects for promotion; liberal expenses while
traveling; exceptional opportunities for extensive traveling; frequent and
intimate contact, both professional and social, with successful men of
recognized standing in the commercial, scientific and legal spheres
particularly, such as presidents and other officers of corporations, leading
manufacturers, U. S. District Attorneys, judges, noted scientific experts, etc.
A
considerable portion of the Inspector's time is spent out of doors, which fact,
together with the great variety of duties involved, makes the work quite
healthful and pleasant. The vast field which is covered by the Food and Drugs
Act of 1906, is decidedly broadening in its effect on the mind and personality
of the inspector, putting the finishing touches or polish to his education, as
it were.
As
the duties of an Inspector are many and varied, covering a tremendous field,
and as every day's work presents new conditions, new problems, different people
and different environments, it will easily be perceived that he has little
cause to complain of monotonous or routine work. The experience and training of
a United States Food and Drug Inspector is looked upon by competent and
judicious critics as a valuable practical course in the best university of the
Universe--the university of life's activities, and the degree conferred by this
university spells "Success" in later life.
Think
of receiving at the hands of the government practical training in typewriting,
correspondence, photography, bookkeeping, methods of transportation, traveling,
court-work, the art of interviewing, general business methods, the collection
of evidence, detective work, the great art of studying and understanding human
nature, to say nothing of the amazingly vast field embracing the manufacturing,
sale and transportation of an inconceivable number of foods, drugs and liquors.
If such an experience does not make a "man" of any one, it is
difficult to imagine what would. It surely will qualify the incumbent to
successfully fill any one of a dozen or more positions in later life.
It
is a significant fact, surprising as it may seem, that there are no more than
forty-five Inspectors throughout this immense territory of ninety million
souls. In other words, the welfare of ninety million stomachs, the most vital
organs of so many proud owners scattered over an area of over three million
square miles--is officially permitted to be in the hands of a handful of
men--forty-five, making it incumbent on one official to look after two million
beings--a shameful and precarious state of affairs. Not much effective work can
be accomplished under present circumstances. The people of this country need
several times the number of Inspectors now employed. Every conscientious
citizen who believes in wholesome food, fit for human beings, should earnestly,
vigorously, and persistently advocate, fight for, and demand a considerable
increase in the present diminutive force.
OFFICE OF CHIEF
INSPECTOR
The
corps of forty-five Inspectors, under a Chief Inspector, who reports directly
to the Chief of Bureau, has headquarters at Washington, and the Inspectors
receive their directions from and make their reports to the Chief Inspector at
that point. The taking of samples for analysis constitutes their chief duty,
though special investigations in collaboration with the chemists are also made,
and factories where articles of food or drugs are prepared, are also inspected.
The Chief Inspector has an assistant who visits the various stations throughout
the country from time to time in a supervisory capacity, suggesting
improvements, criticizing and reporting confidentially to the Chief Inspector,
whose place he assumes during the illness or absence of the latter.
DUTIES OF AN INSPECTOR
To
put it in general and concise terms, the duty of a United States Food and Drug
Inspector is to assist in the enforcement of the Food and Drugs Act of June 30,
1906, by collecting samples of products embraced in that act for analysis,
collecting evidence of the interstate shipment of such products, and pave the
way for the complex machinery of the Department to successfully prosecute
violations of said Federal law.
More
specifically, the primary duties of an Inspector are:
(1) To inspect the stock of foods, drugs, liquors, condiments and
confectionery in the warehouses of manufacturers, jobbers and dealers
(generally wholesale, but occasionally retail) with the object of locating such
products as have been or are about to be transported in interstate commerce and
are adulterated or misbranded within the meaning of the Food and Drugs Act of
1906.
(2) To purchase and collect samples of above products, packing
them properly and forwarding them to a United States Food Laboratory for
analysis.
(3) To collect original, or copies of, records, such as freight
bills, bills of lading, invoices and other written or oral evidence tending to
establish the interstate shipment of products covered by such records.
(4) To confer with United States District Attorneys, United States
Marshals and other Government officials relative to the seizure, destruction or
sale of adulterated, misbranded, poisonous or rotten products, or the
prosecution of any violator of the law.
(5) To accompany the United States Marshal in seizure proceedings,
especially with a view to assisting him in the proper identification of the
commodity.
(6) To act as a witness for the government at trials involving any
violation of the national food law.
(7) To interview dealers, manufacturers, experts, etc., in behalf
of the government and solicit their views on any particular subject for the
benefit of the Department.
(8) To do detective work, such as surveilling factories of
questionable repute, following up wagons or other conveyances suspected of
carrying adulterated or misbranded foods its interstate commerce.
(9) To investigate and report on the condition of industries in a
particular locality, such as the maple sugar industry in New York or Vermont,
the citrus fruit industry in Italy, etc.
Some
of the incidental but necessary tasks of Federal Inspectors are as follows:
Hunting up boxes and other shipping containers, excelsior, nails, hammer,
marking crayon and other promiscuous paraphernalia necessary for the proper
packing and shipping of samples; carrying samples from the dealer's place to
the express or post office; photographing labels on containers having food
products of questionable wholesomeness; tracing labels on the cover of a
barrel; typewriting letters; breaking into freight cars to get a sample of the
contents; disguising as a laborer or "hobo" so as to facilitate the
getting of employment in an establishment suspected of doing "dirty
work," as in the case of the horse-meat sausage factory.
Every
inspector is assigned to a particular city which is considered his official
station or permanent headquarters and is the central or principal point of the
territory covered by him during the year. Stations have from one to four Inspectors
according to the size of the city and the commercial activity of the
surrounding territory, particularly as regards the manufacturing, selling and
interstate transportation of foods and drugs. Stations in cities like Buffalo.
Louisville and Cincinnati, for instance, each have only one man, whereas New
York, Boston, Chicago, St. Louis, etc., have each from three to four
Inspectors, one of whom is known as the "Inspector-in-Charge."
The
time spent on the road by each Inspector, varies according to the general
nature of the territory within his jurisdiction and the business conditions
prevailing at a particular time. On the average, it may be stated, that each
Inspector travels five months of the year, during which time he is allowed
$4.25 per day for board, lodging and personal expenses besides his regular
salary, which varies from $1,400 to $2,500 per annum, and his transportation
expenses.
The
regular hours for work are from 9 A. M. to 4:30 P. M. on week-days and from 9
A. M. to 1 P. M. on Saturdays, except in Washington, where the time is
prolonged to 4 P. M. on Saturdays. While these are the actual hours of service
ordinarily, the inspector is under a technical obligation to work at any time
that the exigencies of unforeseen or special circumstances may demand.
The
day's work is usually begun by reading and answering the mail and mapping out
the work for the day. Should a communication in the form of a letter, telegram
or long distance telephone be received from the Chief Inspector at Washington
requesting an investigation of a particular matter or the performance of some
special task, such an order would precede all other work the Inspector might
have contemplated. In the absence of any such assignment to a special duty, our
"pure food guardian" will sally forth on his usual inspection tour,
visiting wholesale grocers and druggists, factories, spice and grain mills,
packing houses, docks, wharves, railroad freight depots and every other
locality where he is likely to find food and drug products that have been or
will be transported in interstate commerce.
METHOD OF PROCEDURE
On
locating a questionable consignment that is to be shipped out to another state, territory or the District of Columbia,
the Inspector makes a note of the name and address of the consignor (he who
forwards the goods), the name and address of the consignee (he to whom the
goods are being forwarded), the quantity or size of the shipment and the label
on the shipping container. He will then forward such information to the office
of the Chief Inspector as well to the official station nearest to the point of
destination of such a consignment, after which the products in question will be
followed up and sampled after delivery to consignee.
On
the other hand, if the consignment of adulterated, misbranded, poisonous or
decayed food, was sentfrom an outside state,
territory or the District of Columbia, the Inspector will proceed to collect an
official sample of such unwholesome food as follows: (1) He will break open one
or more "original, unbroken" packages and get a representative sample
or one representing the average condition of the greater part of the products.
(2) He will pay for said sample whatever price the dealer may demand and will
request the dealer to sign a receipt for such purchase price. This receipt also
states that the dealer identifies the goods sampled as a shipment covered by
submitted (original or copy of) invoice, and submitted (original or copy of) shipping
memorandum, which statement is intended to aid the Government in proving that
the shipment of the products sampled was an interstate one. (3) He will obtain
the original or copies of the invoice and shipping memorandum such as freight
bill or bill of lading. (4) He will take a photograph, tracing or copy of the
label on the original, unbroken shipping package from which he took the sample.
(5) He will be careful not to leave the sample out of his possession and
personal care, as he will be held responsible for same from the moment he takes
it. (6) He will carefully pack such sample, after making three or more
subdivisions, and forward it to some United States Food Laboratory for
analysis. (7) He will submit the records collected to the Chief Inspector as
well as a "report on collection," a copy of which he will keep.
Should
the chemist's analysis reveal a violation of the Food and Drugs Act, any one of
several courses may be pursued by the Department. The manufacturer or dealer
responsible for the violation may be called upon for a hearing before the Board
of Food and Drug Inspection, when he will be given an opportunity to explain.
Should he explain to the satisfaction of that august body that the apparent
violation was accidental, unavoidable or otherwise excusable, the matter can be
speedily and satisfactorily adjusted. If no satisfactory and convincing excuse
is offered, the Department may resort to litigation, and if successful may
attach or seize the goods pending trial, destroy, sell, or return them to the
defendant provided he put up a bond that he will property modify the label or
remanufacture the products or otherwise conform to the Federal Law. It is very
rarely that the Department resorts to prosecution against the person of an
offender, so that exceedingly few, if any, defendants have been sentenced to
imprisonment. The most prevalent punishment meted out to offenders is in the
form of a moderate fine. Keen rivalry exists among the Inspectors as to who can
obtain the greatest number of seizures.
A
successful Inspector should possess, besides the necessary qualifications for
eligibility, such assets as judgment, initiative, tact and energy. He should be
diplomatic, keenly observant, a good "mixer," a patient and silent
listener and a practical student of human nature and business affairs.
There
is no doubt that our country has a considerable number of ambitious youths
endowed with the above invaluable qualities who could do much in their official
capacity as Federal Inspectors to improve sanitary conditions prevailing in our
present food and drug factories and promote the welfare and well-being of
ninety million bodies by insuring them wholesome, nutritious and fresh articles
of diet.
While
the excellent personnel of the present force of Food and Drug Inspectors and
the spirit of aggressiveness and fearlessness displayed by the men, is a
compliment to the Department of Agriculture, particularly to Secretary Houston
and Chief Carl L. Alsberg, it is nevertheless to be deeply regretted that
Congress does not recognize and act upon the fact that their exceedingly
limited number necessarily hampers and restricts the effectiveness of their
work, upon which depends to so great an extent the health and welfare of the
American public.
HOW TO BECOME A UNITED STATES
FOOD AND DRUG INSPECTOR
While
no definite announcement has yet been issued by the United States Civil Service
Commission relative to the holding of an examination for the position of United
States Food and Drug Inspector, there is nevertheless good cause to assert that
an examination for this position will be held within a year, and it is strongly
advisable for all ambitious candidates to begin their preparation now as at
least a year's preparation is quite essential to the securing of a place on the
eligible list.
Qualifications
for Eligibility.--Applicants possessing any one of the following qualifications will be eligible
to take the examination and for appointment:
(a) Practical experience in an establishment manufacturing or
dealing in foods, drugs, liquors or confectionery.
(b) Traveling experience as a representative of a food, drug,
liquor or a confectionery concern.
(c) Completion of a course in the adulteration of foods and drugs.
(d) Completion of a course in chemistry.
(e) Completion of a course in medicine or pharmacy.
(f) Possession of the degree of M.D. or Ph.G.
CAPA NOTES FOR PHARMACEUTICAL INDUSTRY
CAPA NOTES FOR PHARMACEUTICAL INDUSTRY
COPY AND PASTE BELOW LINK
https://www.facebook.com/download/820448368074255/CAPA%20BY%20PJ%20DIPAK%20RATHORE.pdf
OR
CLICK CAPA GREEN COLOR WORD TO ACCESS DRIECT.
DIRECT LINK --> CAPA
COPY AND PASTE BELOW LINK
https://www.facebook.com/download/820448368074255/CAPA%20BY%20PJ%20DIPAK%20RATHORE.pdf
OR
CLICK CAPA GREEN COLOR WORD TO ACCESS DRIECT.
DIRECT LINK --> CAPA
Teva Pharmaceuticals SEND CV process
Executive – Quality Assurance Support - Job Opening at Mumbai site for Teva Pharmaceuticals,
Qualification-B. Pharm/ M. Pharm/ M. Sc,
Experience- 2-4 years’ experience in QA, QC, Production in a Pharmaceutical Manufacturing unit.
Candidates having prior experience in reviewing and compiling of Annual Product reviews will be preferred.
· Review, evaluation and compilation of APQRs.
· Compiling of quality data, performing trend analysis, tracking and reporting deviation trends in
APQR’s and ensure accuracy and completeness of data.
· Evaluate reviews, recommend actions and professionally communicate to sites so as to continually
improve quality of products.
· Management of Documents, ensuring proper storage/archival and retrieval of documents.
· Carrying out any task delegated by Management which contribute to overall running of the
department e.g. assistance with different ongoing projects.
If any body interested send the resume to me on
dileep.dra@gmail.com.
Qualification-B. Pharm/ M. Pharm/ M. Sc,
Experience- 2-4 years’ experience in QA, QC, Production in a Pharmaceutical Manufacturing unit.
Candidates having prior experience in reviewing and compiling of Annual Product reviews will be preferred.
· Review, evaluation and compilation of APQRs.
· Compiling of quality data, performing trend analysis, tracking and reporting deviation trends in
APQR’s and ensure accuracy and completeness of data.
· Evaluate reviews, recommend actions and professionally communicate to sites so as to continually
improve quality of products.
· Management of Documents, ensuring proper storage/archival and retrieval of documents.
· Carrying out any task delegated by Management which contribute to overall running of the
department e.g. assistance with different ongoing projects.
If any body interested send the resume to me on
dileep.dra@gmail.com.
MEDICAL CODING JOB:- FRESHER , B-PHARM, M-PHARM, B.sc, M.sc & FINAL YEAR STUDENTS ALSO APPLY FOR POST. INTERVIEW DATE:- NOV:- 30 , DECEMBER:- 1, 2 & 3. SO soon attend limited vacancy
Dear candidate,
During attending Interview please keep updated CV with you & mention reference on cv RATHORE DIPAK .
Don't forgot to mention reference in cv, it will helpful for you in future. Make reference my name (RATHORE DIPAK ) on CV at upper side and during application form mention my reference so i can help you more.
When you reach office for interview give my name on reception or call me or whatsapp for any help.
Don't worry about charges,here no charge taken from you or anyone ... it's always free so just attend and get job and make future.
So i inform regarding interview date and venue and time.
Address: 511, Pinnacle Business Park, Near Safal Profitaire, Prahladnagar Road, Satellite AHMEDABAD,Gujarat,India.
Conatct:- 9722262747
Date:- NOV:- 30 , DECEMBER:- 1, 2 & 3. SO soon attend limited vacancy
TIME:- 10:00 AM TO 03:00 PM
Qualification: B.pharma, M.pharma, B. sc, M. sc. or any science graduate
FINAL YEAR STUDENTS ALSO APPEAR FOR INTERVIEW.
Salary scheme for fresher:
1-6 months 9600 + attractive bonus
7-12 months 10000 + attractive bonus
13-24 month 14000 + attractive bonus
1-6 months 9600 + attractive bonus
7-12 months 10000 + attractive bonus
13-24 month 14000 + attractive bonus
IF YOU GOING FOR INTERVIEW REPLY SOON, SO I CAN ARRANGE FOR YOU.
PHARMA JOBS:- PJ
A FREE SERVICE SINCE 18 MONTHS, MORE THAN 850 CANDIDATES GOT JOB TILL NOW.
THANKS
DIPAK RATHORE
PHARMA JOBS-PJ
ADMIN
9722262747 ONLY WHATSAPP....
Friday, 27 November 2015
CIPLA BANGLAORE :- Walkin for HPLC Analyst on 28 Nov'15, 10am - 2.30pm, Bommasandra Plant
Dear Candidates,
Cipla invites candidates for Walkin interview having 3-6 yrs of relevant experience in API / Formulations QC HPLC.
Interested candidates can Walkin with their updated CV, Pay slips at below address:
Cipla Ltd
Plot No. 285,286 & 287
Bommasandra, Jigani Link Road.
Industrial Area, KIADB 4TH PHASE,
Jigani (P), Anekal (T)
Bangalore - 560105
Plot No. 285,286 & 287
Bommasandra, Jigani Link Road.
Industrial Area, KIADB 4TH PHASE,
Jigani (P), Anekal (T)
Bangalore - 560105
Contact Person : Kavitha P H
Ph No: 080-22059269
Job Description as follows:
Analysis by HPLC & GC
Chromatographic interpretation
Non Chromatographic analysis like IR, UV, Particle Size, AAS, Titrator
Experience in FDA/TGA/WHO approved Labs
Chromatographic interpretation
Non Chromatographic analysis like IR, UV, Particle Size, AAS, Titrator
Experience in FDA/TGA/WHO approved Labs
BIOCON 29 NOV. 2015 - WALK-IN AT HYDERABAD for API, INJECTABLE & INSULIN DEPT.
Candidates should bring five passport size photos, two copies of their CV, payslip, copies of educational certificates, previous work experience certificates & salary annexure.
Venue:
Hotel Sree Krishna Grand
Plot No: 20 & 32, Miyapur X Roads,
Hyderabad
Date: Sunday, 29th Nov 2015
Time: 9:00AM- 02:00PM
Plot No: 20 & 32, Miyapur X Roads,
Hyderabad
Date: Sunday, 29th Nov 2015
Time: 9:00AM- 02:00PM
LINK FOR PIC IF NIT CLEAR SEEN:- http://company.naukri.com/biocon-jobs/index.html
Loctose India Limited FRESHERS
mention my reference:- If any require urgent job as a freshers in Qa,Qc and Production then send me updated resume on hiteshdk01@gmail.com
company : Loctose India Limited
Survey No. 06|Vill :Poicha (Rania)|
Tal : Savli|Dist : Vadodara|Gujarat - 391780|INDIA|
BANGALORE, HEYDARABAD , VIJAYVADA JOBS UPDATE
Hiring for the following positions :
1.AGM / Sr. Manager - QC & QA (2 different positions) API for a leading Pharma Company based @ Hyderabad.
2.Associate Director - Strategic sourcing (R&D PURCHASE) for FORMULATION STERILE for a leading Pharma Company based @ Bangalore.
3.Associate Director - Packaging Material for FORMULATION STERILE for a leading Pharma Company based @ Bangalore. should have exposure in handling primary and secondary packaging experience, expertise in commercial aspects.
4.For several open positions, looking for suitable candidates with 10+ years of experience in pharmaceutical HR (Plant / Corporate / R&D).
5.Head - Analytical (NDD) for leading Pharma Company based @ Hyderabad. No 1 position in Analytical discovery, will look after team of around 20+ scientists.
6.DGM / AGM - API QA (USFDA) approved plant)for a leading Pharma Company based @ Hyderabad.
7.Sr. Manager / Manager - Green field Projects formulation (Solid Orals) for a leading Pharma Company based @ Jagayapeta Near vijaywada AP.
Email resumes on : Krutika@bigpharmajobs.in or call on +91 99040 01192...
PJ BOOMING @ 3 PLACE NOW
PJ @ 3 PLACE NOW
1.FACEBOOK:- https://www.facebook.com/groups/pharmajobsdk619/
2.WHATSAPP:- ONLY FOR WHO CAN UPDATE JOBS NOW.
3.BLOGGER:- http://pjbydipakrx.blogspot.in/
PJ MOTTO:-- SHARE MAXIMUM TO GET MAXIMUM....
SHARE WITH YOUR FRIENDS TO JOIN US.
Quintiles Walk in for PV on 28 th November
Quintiles Walk in for PV on 28 th November
Open Walkin for Pharmacovigilance
Experienced(2+ in pv) on 28th Nov
Experienced(2+ in pv) on 28th Nov
2 - 7 yrs Bengaluru/Bangalore
Event details:
Date- 28-Nov-2015
Registration Timings - 8 am to 9:30 am
Documents to carry Copy of this mail, Updated CV, Id proof (For experienced candidates :: last 3 months pay slip, latest compensation break up letter)
Documents to carry Copy of this mail, Updated CV, Id proof (For experienced candidates :: last 3 months pay slip, latest compensation break up letter)
Assessment process - CV screening->Aptitude->HR Interview->Technical interview->Final interview
Job location - Bangalore
Num of openings - Multiple.
Contact person Kavya L / A Shamshuddin
Interview Location
Quintiles
Etamin Block, Wing B, Ground floor
Prestige Tech Park II, Outer Ring Road
Sarjapur, Bangalore - 560103
Quintiles
Etamin Block, Wing B, Ground floor
Prestige Tech Park II, Outer Ring Road
Sarjapur, Bangalore - 560103
Visit our homepage www.quintiles.com/careers to know more about us.
Note:- Prefer candidates who can join before 28th Dec'15.
USFDA:- Inspections, Compliance, Enforcement, and Criminal Investigations
Shocking warning letter for Dr Reddy.
They hide a full QC lab from USFDA and conducted tests in the same. Whole letter highlights data integrity issues through and through. Too bad
: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm473604.htm
They hide a full QC lab from USFDA and conducted tests in the same. Whole letter highlights data integrity issues through and through. Too bad
: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm473604.htm
Dr Reddy's gets a breather after USFDA gives more time to respond to warning letter
Hyderabad: Dr Reddy's Laboratories Ltd (DRL) today said the USFDA has extended the time-frame for replying to the warning letter issued to the company by about two weeks to 7 December.
The company also said that it is in the process of preparing responses to the letter on November 5 by the US Food and Drug Administration.
"The company is in the process of preparing a response to FDA's warning letter. The FDA has granted an extension until December 7, 2015 for the submission of the company's response to its warning letter," Dr Reddy's said in a regulatory filing.
Its stock tanked by 8.21 percent to Rs 3,110.35 on BSE on the likely impact of the warning.
The FDA had earlier set a deadline for the company to respond within 15 days from the date of receiving the letter.
The FDA, which issued a warning letter to Dr Reddy's Laboratories on 5 November on three of its plants, said it found several violations with regard to current good manufacturing practices (CGMP).
The US regulator cautioned that it may withhold approval to any new drugs or Active Pharmaceutical Ingredients (API) and stop importing if the company "fails to correct the violations".
It said its inspectors have discovered "an uncontrolled custom QC laboratory (CQC)" at DRL's Srikakulam unit.
The letter had asked Dr Reddy's for a third party assessment of comprehensive evaluation of the extent of
inaccuracies in recorded and reported data.
inaccuracies in recorded and reported data.
It also called to include a detailed action plan to fully investigate the extent and root causes of the deficient documentation and data management practices.
The letter also asked for a management strategy that includes global corrective action and preventive action.
The country's second-largest drug maker last week said it received a warning letter from the US drug regulator relating to two of its API manufacturing plants and a formulation plant located in Andhra Pradesh and Telangana.
DRL had said in the earlier filing that "it has received a warning letter issued by the US FDA dated 5 November 2015 relating to its API manufacturing facilities at Srikakulam in Andhra Pradesh and Miryalaguda in Telangana, as well as Oncology formulation manufacturing facility at Duvvada, Visakhapatnam in Andhra Pradesh".
PTI
Thursday, 26 November 2015
Lupin, nagpur, QC 25 Vacancies
Vacancy in Lupin in QC department
Lupin Nagpur have 25 vacancies for Qc department ,
interested person send resume to
deepakkhare1@lupin.com
EXp require 1 year to 5 year
Rubicon, Mumbai
Vacancy in Rubicon Research Pvt. Ltd.-
Urgent requirements of Technician/Machine Operators in Tablet/ Capsule Production Department.
Company Name: Rubicon Research Pvt. Ltd.-
USFDA /MHRA approved.
Vacancies: 25Nos.
Job Location: Ambernath, near to Mumbai.
Job profile:
Candidate must have more than 6 months relevant exp.
Mumbai/Maharashtra based candidates would be preferred.
Should have exposure into Granulation/Compression/Coating and Packing area.
Interested candidates may apply on machhindra@rubicon.co.in
Troikka pharmaceutical, Ahmedabad
Vacancy in troikaa pharma,Ahmedabad
Experience required for the Job: 2 - 5 years
Annual Salary of the Job: 1.0 - 3.0 Lacs
Job Location: Ahmedabad
Apply Now Reply
Dear Candidate,
Desirable Qualification : Post Graduate from science stream
Job Description:
1. Reciept of Rm / Pm
2. Dispensing Rm / Pm
3. CGMP records
4. Storage of Rm /Pm
5. Prepare monthly statement
6. Preparation of goods receipt
7. Operation, Calibration & Weight verification
If you are interested, please revert your resume on
career@troikaapharma.com
With best Regards,
Anjali Chaudhari
Kemwell pharmaceutical, Bangalore, 28 NOVEMBER
Kemwell Biopharma Pvt Ltd,Banglore , Walk in on 28 th November
Company : kemwell pharma Pvt Ltd
Location :bangalore ,neelamangala.
Department : production
Experience : 2 years and above
position : Executive & Technician (production)
venue: Kemwell Biopharma Pvt Ltd., 34th Km, T.Begur, Nelamangala Taluk, Bangalore Rural District, Karnataka - 523123,,
Time : 9 am to 2 pm.
Zydus Cadila - Apprentice freshers 30 November
Dear Candidate,
Dear Professionals,
Greetings from Cadila Healthcare Limited (Zyduscadila) !
Company Profile:
Zydus Cadila is an innovative global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare products. The groups operations range from API to formulations, animal health products and cosmeceuticals. Headquartered in the city of Ahmedabad in India, the group has global operations in four continents spread across USA, Europe, Japan, Brazil, South Africa and 25 other emerging markets.
In its mission to create healthier communities globally, Zydus Cadila delivers wide ranging healthcare solutions and value to its customers. With over 18,000 employees worldwide, a world-class research and development center dedicated to discovery research and eight state-of-the-art manufacturing plants, the group is dedicated to improving peoples lives.
Opening in Zydus Cadila:
Department:- Tablet/ Capsule Manufacturing
Education:- B. Pharm(2014-2015 Pass out Only).
Designation:- Apprentice(1 year Apprentice).
ONLY MALE CANDIDATE
ONLY B.PHARM CANDIDATE IS ELIGIBLE FOR INTERVIEW.
Time:- 10:00 AM to 14:00 PM
Date:- 30.11.2015
Interview Venue:-
Cadila Healthcare Limited (Zyduscadila)
Sarkhej-Bavla NH-8A,
Moraiya, Sanand,
Ahmedabad - 382210
Interested Candidate may "Walk-In Interview on 30.11.2015."
Regards,
Hardik Pandya
HR Dept.
Cadila Healthcare Ltd.
ACME PHARMACEUTICAL
Company Name : Acme Pharmaceuticals Pvt. Ltd.
Company URL : www.acmegrp.in
divya@darshsolutions.in
Job Location : Ahmedabad, Sanand
·
Experience : 1-3 Years
Designation : Production Officer
Qualifications : M.Pharm/ B.Pharm
Job Description:
Ø Should have worked in injection department in Pharma.
Please forward me your updated CV with below mentioned details:
Current CTC:
Expected CTC:
Current Location:
Permanent Location:
Total Years of Experience:
Relevant Experience:
Current Designation:
Current Company:
Notice Period of your present company:
Thanks & Regards,
Divya Parmar DARSH SOLUTIONS INC
PIRAMAL, ADL DEPARTMENT 28 NOVEMBER Ahmedabad
We have urgent requirement for Bsc and Msc for ADL department.
- Candidate should have an orientation towards Analytical Development Lab.
-Should be flexible with working hours and should have good working attitude.
- Good knowledge of Organic synthesis and analytical methods.
- Good communication skills.
- Experience - 1 to 2 years
Note: 1. Candidates who have already appeared will not be consider for this walk-in.
2. Interested candidate can directly come down for interview.
3. Please bring your updated CV and 1 passport size photograph.
Interview Date - 28 st November '2015 (Saturday)
Time: 10:00 AM to 3:00 PM
Venue - Piramal Enterprises Ltd. (Discovery Solutions)
Plot#18 Pharmaceutical Special Economic Zone
Village Matoda, Sarkhej Bavla NH#8A
Taluka Sanand
District -Ahmedabad, Gujarat 382213
India
Job location - Ahmedabad
Job Description
Analysis of RM,PM, FP, INPROCESS,etc...
Daily calibration of analytical balance,moisture analyzer,hygrometer,etc....
Handling GC,Dissolution appratus,karl fischer,polarimrter, HPLC,UV-Visible Spectrophotometer,moisture analyzer,etc... good knowledge of Analytical method developement,modern analytical techniques..etc
API PLANT:- HEYDRABAD
Hiring for the position of AGM / Sr. Manager / Manager - QA API for a leading Pharma Company based @ Hyderabad.
Email resumes on : Krutika@bigpharmajobs.in or call on +91 99040 01192
REFERENCE:- DIPAK RATHORE
Email resumes on : Krutika@bigpharmajobs.in or call on +91 99040 01192
REFERENCE:- DIPAK RATHORE
ZYDUS CADILA 28 NOVEMBER, INDORE, MP
Walk-In Interview
Zydus Cadila is one of India's leading healthcare companies and a global healthcare provider with strengths all along the pharmaceutical value chain. The group's state-of-the-art manufacturing infrastructure is spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim. The group's formulation manufacturing hub at Moraiya, Ahmedabad has received approvals from several regulatory authorities.
In keeping with its ethos of 'We build people to build our business' the group has created a benchmark in HR practices and uses scientific and objective methodologies like psychometric tools, in-house Assessment Centres etc., as a part of its recruitment process.
If you have the talent and the zeal here's an opportunity for you to join our manufacturing plant at Ahmedabad as:
WALK-IN INTERVIEW
Date : 28th November 2015, Saturday
Timings : 9.30 a.m. to 5.00 p.m.
Venue : Hotel Lemon Tree, 3 - R.N.T. Road, Indore 452001. Madhya Pradesh.
Contact : +91 731 4423232
Manager / Deputy Manager - Technical Agreement
Corporate Audit & Compliance : M.Pharm / M.Sc. with
12 to 15 years of relevant experience to prepare draft quality agreements based on commercial / supply agreements or business requirements and other agreements related to technical consultants and service providers.
Manager - Market Complaints
Corporate Quality Assurance : M.Sc. / M.Pharma with 12 to 15 years to prepare, quality complaint log and maintain complete list of all market complaints as per corporate guidelines. To track the complaint log market-wise, nature of complaint, cause and CAPA.
Manager - Master Data Cell
Corporate Quality Assurance : B.Sc. / M.Sc. (IT) / B.Pharm with 12 - 15 years of relevant experience to support smooth working of SAP, complete safety of master data in SAP and knowledge of working in different SAP module to monitor SAP activities at a manufacturing plant.
Officer / Executive / Sr.Executive
Corporate Quality Assurance - Loan Licensing : B.Pharm / M.Pharm / M.Sc. with 4 to 12 years of hands-on experience of audit of external vendor & internal audits (loan license sites & contract manufacturing sites) of formulations. Should also have sound knowledge of compliance and be well versed with QMS of formulations (OSD, Injectable & Liquid).
For all the positions, candidates must have exposure to regulatory requirements of documentation and cGMP/GLP . Those with experience in SAP environment shall be preferred.
Interested candidates may "Walk-in" for an interview along-with their updated CVs and relevant documents as per below schedule.
Chemist / Officer / Executive / Sr.Executive
QA in QC (Analytical QA) : M.Sc. / B.Pharm with 4 to 8 years of hands-on experience of review on analytical reports, chromatographic data, stability protocols, investigation of OOS & OOT.
Quality Control Micro : M.Sc. (Microbiology) with 2 to 8 years of experience & knowledge of validation of methods, equipment, autoclave, LAF area, water system, bio-assay, BET test, sterility test & microbiological activities of pharmaceutical industry is a must.
Quality Control : B.Sc. / B.Pharm / M.Sc. with 2 to 8 years of hands-on experience of HPLC, GC, dissolution apparatus and UV-visible spectrometer. Should also have knowledge of weight analysis and stability studies for parenteral preparations and solid dosage forms.
Quality Reviewer : B.Sc. / B.Pharm / M.Sc. with 8 to 10 years of experience in review of analytical data and exposure to investigation of out of specification, out of trend and laboratory investigation.
Officer / Executive / Sr.Executive
Quality Assurance : M.Sc. / B.Pharm with 2 to 8 years of relevant experience of qualification, validation & IPQA activities in solid oral & parenteral manufacturing facilities.
Officer Master Data Cell - CQA : B.Sc. / M.Sc. (IT) / B.Pharm with
2 to 5 years of experience on IT SAP operation. Should have background of SAP / MDC in pharmaceutical company and hands-on experience of SAP transaction.
Executive - Market Complaints
Corporate Quality Assurance : M.Sc / B.Pharm / M.Pharm with 4 to 7 years of experience in maintaining quality complaint log and list of all market complaints. Will be in-charge of tracking the complaint log and analyzing market-wise, location-wise nature of complaint and their cause.
Dy. Manager / Manager
Quality Assurance : M.Sc. / B.Pharm with 5 to 12 years of relevant experience of qualification, validation & IPQA activities in solid oral & parenteral OSD manufacturing facilities.
Interested Candidates may also email their resume to
hr.mfg@zydusmail.com or send it by courier to the
Human Resource Department, Cadila Healthcare Ltd.,
Sarkhej-Bavla NH-8A, Moraiya, Taluka-Sanand,
Ahmedabad-382210 within 7 days.
www.zyduscareers.com
Thanks & Regards
Harshil Bhatt
HR Department
Cadila Healthcare Ltd
FARMSON- VADODRA
Dear Candidate,
Farmson is a world class, large scale manufacturing company located in Vadodara partnering with market leaders to offer pharmaceutical products and services.
Currently we are looking for Dynamic Candidate who would be joining us in Quality Assurance Dept,
If interested please revert back within 7 days with your updated cv ongeneral.hr2@farmsom.com with Subject Line : CV for QA
Please revert us with your current & expected CTC.
Thanks & Regards,
Anju Singh
HR.
Farmson Analgesics
28-35, GIDC Ind. Estate
Farmson is a world class, large scale manufacturing company located in Vadodara partnering with market leaders to offer pharmaceutical products and services.
Currently we are looking for Dynamic Candidate who would be joining us in Quality Assurance Dept,
If interested please revert back within 7 days with your updated cv ongeneral.hr2@farmsom.com with Subject Line : CV for QA
Please revert us with your current & expected CTC.
Thanks & Regards,
Anju Singh
HR.
Farmson Analgesics
28-35, GIDC Ind. Estate
WELCOME PJ BLOG
WELCOME TO NEW SERVICE OF PHARMA JOB-PJ.
I AM VERY THANKFUL TO ALL MY FRIENDS TO GIVE SUCH BIG SUPPORT TO DO SOMETHING FOR PHARMA AND PHARMA PEOPLES BY UPDATES JOBS AND PROVIDE SOME INFORMATION WHICH MAY USEFUL FOR MAKE YOUR AND MY BETTER FUTURE.
I REQUEST TRY TO UPDATE, SHARE & SEARCH NEW JOBS FOR PHARMA PEOPLES.
SHARE MORE, GET MORE
UPDATE MORE, GET MORE
JOIN MORE, GET MORE
PHARMA JOB-PJ
DIPAK RATHORE
I AM VERY THANKFUL TO ALL MY FRIENDS TO GIVE SUCH BIG SUPPORT TO DO SOMETHING FOR PHARMA AND PHARMA PEOPLES BY UPDATES JOBS AND PROVIDE SOME INFORMATION WHICH MAY USEFUL FOR MAKE YOUR AND MY BETTER FUTURE.
I REQUEST TRY TO UPDATE, SHARE & SEARCH NEW JOBS FOR PHARMA PEOPLES.
SHARE MORE, GET MORE
UPDATE MORE, GET MORE
JOIN MORE, GET MORE
PHARMA JOB-PJ
DIPAK RATHORE
MEDICAL CODING- AHMEDABAD
FRESHER & EXPERIENCE BOTH CAN APPLY.
Medical coder vacancy
Place: Ahmedabad - guajarat
Place: Ahmedabad - guajarat
Qualification: B.pharma, M.pharma, B. sc, M. sc. or any science graduate
Salary scheme for fresher:
1-6 months 9600 + attractive bonus
7-12 months 10000 + attractive bonus
13-24 month 14000 + attractive bonus
1-6 months 9600 + attractive bonus
7-12 months 10000 + attractive bonus
13-24 month 14000 + attractive bonus
Interested candidate contact me
+91-9722262747 CALL or whatsapp also.
+91-9722262747 CALL or whatsapp also.
or send your cv @ subject should be MEDICAL CODING.
pharmajobsrx@gmail.com
pharmajobsrx@gmail.com
Freshers can also apply.
IF THIS NOT FOR YOU SHARE WITH YOUR PHARMA FRIENDS.
LUPIN APPROVAL
New Delhi: Lupin on Tuesday said it has received final approval from the US Food and Drug Administration to market Blisovi oral contraceptive tablets in different strengths in the American market.
"The company has received final approvals from the United States Food and Drug Administration (US health regulator) to market generic versions of Warner Chilcott's Loestrin Fe 1/20 tablets and Loestrin Fe 1.5/30 tablets", Lupin said in a statement.
Lupin's US subsidiary - Lupin Pharmaceuticals Inc - shall commence promoting the product in the US shortly, it added.
The tablets are indicated for prevention of pregnancy in women who chose to use oral contraceptives.
According to IMS MAT data, Loestrin Fe 1/20 had US sales of $139.7 million while Loestrin Fe 1.5/30 had sales of $55.5 million.
Shares in Lupin, on Tuesday, ended 1.12 per cent higher at Rs 1,860.35 apiece on the BSE, whose benchmark Sensex index finished down 0.17 per cent.
MACLEODS:- 3-4 DECEMBER HARIDWAR, UTTRAKHAND
WALK IN INTERVIEW
Macleods, India’s fastest growing pharmaceutical company, with manufacturing sites approved by USFDA & WHO Geneva, ranked among the top pharmaceutical companies with strength of 10,000 employees, operating 60 + countries worldwide, required talented professionals for Formulation Plants.
Quality Control
Officers– Quality Control. (Required - Formulation Plant - Sikkim, Daman , Baddi)
Qualification: B. Sc/ M sc / B Pharma / M Pharma
Experience 2-6 years - Raw Material, Finished Product & Stability, with experience on Analytical Instrumentation - HPLC, GC, and UV IR.
Qualification: B. Sc/ M sc / B Pharma / M Pharma
Experience 2-6 years - Raw Material, Finished Product & Stability, with experience on Analytical Instrumentation - HPLC, GC, and UV IR.
Production Department
Officer – Production. (Required - Formulation Plant - Sikkim, Daman & Baddi)
Qualification: B Pharma / M Pharma
Experience 2-8 years (Granulation/compression/coating), Strip/blister, Bulk packing.
Qualification: B Pharma / M Pharma
Experience 2-8 years (Granulation/compression/coating), Strip/blister, Bulk packing.
Technical Associate- Production (Required - Formulation Plant - Sikkim & Baddi)
Qualification: ITI/ Diploma
Experience 2-8 years - Granulation /compression /coating /Strip /blister & Bulk packing machine.
Officer– Production (Injectable) (Required - Formulation Plant - Sikkim)
Qualification: B Pharma / M Pharma
Experience 2-8 years - (Dry Powder Injection)
Qualification: ITI/ Diploma
Experience 2-8 years - Granulation /compression /coating /Strip /blister & Bulk packing machine.
Officer– Production (Injectable) (Required - Formulation Plant - Sikkim)
Qualification: B Pharma / M Pharma
Experience 2-8 years - (Dry Powder Injection)
Technical Associate- Production (Injectable) (Required - Formulation Plant - Sikkim) Qualification: ITI/ Diploma
Experience 1-8 years - Filling, Sealing, Cartonators.
Experience 1-8 years - Filling, Sealing, Cartonators.
Please WALK –IN interview - 9.30 -18.30 Hrs with CV, Salary proof on following date & Places
Date -3rd / 4th December
Hyphen Grand Hotel
Pentagon Mall , Sector-12, Haridwar
Uttarakhand
Mob. 08894755504, 08126009620
Date -3rd / 4th December
Hyphen Grand Hotel
Pentagon Mall , Sector-12, Haridwar
Uttarakhand
Mob. 08894755504, 08126009620