Walk-in for Quality Assurance , Production , Quality Control , Process Engineering on 18th March 2016 at Indore
Here is a chance to join Zydus at our API Manufacturing located at Ankleshwar as.
Key Responsibilities are mentioned as below:
QUALITY ASSURANCE : Sr.Executive / Executive : M.Sc./ B.Sc Chemistry with 4 - 8 year , must be familiar with cGMP requirements, Data Integrity, Document Cell, Batch release process, Trending APR shop floor Operation in API / Bulk Drug
Manufacturing.
a) Data Integrity - Responsible to review of HPLC and GC , QC Sop Compliances, Investigation activities , OOS and OOT and quality control instruments.
b) Document Cell -Review of documents before DMF submissions, distribution / Issuance of BMRs, Master Formulae, SOPs and Formats to the respective departments and controlling all master documents.
c) Batch Release - Knowledge of ICH guidelines and should review of BMRs and Validation documents and to give usage decision and dispatch of all APIs and salable intermediates in LIMS and SAP.
d) Technology transfer documents - Review R&D process & TTD, evaluation of CPP & CQA and comparison with batch record , review of master batch record also review of specification and STP of API, Intermediate, RM, In-process.
e) Trending and APR - Knowledge of Market complaint, Deviation, Incident, Change control for trending of Systems, Review of Master SOPs, BMRs, PCRs, validation Protocols and reports and Annual Review reports.
Manufacturing.
a) Data Integrity - Responsible to review of HPLC and GC , QC Sop Compliances, Investigation activities , OOS and OOT and quality control instruments.
b) Document Cell -Review of documents before DMF submissions, distribution / Issuance of BMRs, Master Formulae, SOPs and Formats to the respective departments and controlling all master documents.
c) Batch Release - Knowledge of ICH guidelines and should review of BMRs and Validation documents and to give usage decision and dispatch of all APIs and salable intermediates in LIMS and SAP.
d) Technology transfer documents - Review R&D process & TTD, evaluation of CPP & CQA and comparison with batch record , review of master batch record also review of specification and STP of API, Intermediate, RM, In-process.
e) Trending and APR - Knowledge of Market complaint, Deviation, Incident, Change control for trending of Systems, Review of Master SOPs, BMRs, PCRs, validation Protocols and reports and Annual Review reports.
PRODUCTION : Sr.Executive / Executive: Diploma /B.E / B.TECH (chemical) M.Sc./ B.Sc. (Chemistry) with 4 to 7 years of experience and relevant exposure in API / Bulk Drug Manufacturing. Should also have knowledge of GMP documentation. Must be familiar with cGMP requirements.
QUALITY CONTROL : Sr.Executive / Executive : M.Sc /B.Sc (Chemistry) with 4 - 8 years of hands on experience and relevant exposure in handling instruments like HPLC, GC, UV , wet lab and chemical analysis of Raw Material . Must be familiar with cGMP requirements. Shop floor Operation in API / Bulk Drug Manufacturing.
Process Engineering : Executive / Sr.Executive: B.E / B.TECH (chemical) with 4 to 6 years of experience and relevant exposure in API / Bulk Drug Manufacturing. Design of equipment, piping & facility. Solvent recovery. Heat & Mass balance. Capacity debottlenecking.
Investigation Positions in QA / CQA: From Production (M.Sc.) / QC (M.Sc.) / Process engineering (B.E. Chem) / Process development (M.Sc. / Ph.D.): Sr. Executive / Executive
Should have knowledge of investigation tools and technics.: Flow chart, Parato chart, Fishbone tech., Brain storming, 5 Why tech
Should be well versed with statistical analysis technics and data evaluation: ANOVA, Regression, Correlation, Minitab software.
Should be competent in Quality Risk Assessment technics: FMEA, Fault tree analysis.
Should have through knowledge of pharmaceutical manufacturing processes: Unit operation and unit processes, Mixing, Blending, Type of reactor and agitators etc.
Should have experience in handling of failure investigations: OOS, OOT, market complain, deviations.
Should have experience / knowledge of working principles of quality control instruments, HPLC, GC, XRD etc.
Should have handled Phase-I and Phase-II investigations.
Should be conversant for utilization of Minitab software and Microsoft excel for data evaluation.
Should have knowledge of report writing, technical writing and presentation skill.
Should have knowledge of relevant regulatory guidelines, ICH-Q7, ICH-Q9, USFDA OOS investigation etc..
Should have knowledge of investigation tools and technics.: Flow chart, Parato chart, Fishbone tech., Brain storming, 5 Why tech
Should be well versed with statistical analysis technics and data evaluation: ANOVA, Regression, Correlation, Minitab software.
Should be competent in Quality Risk Assessment technics: FMEA, Fault tree analysis.
Should have through knowledge of pharmaceutical manufacturing processes: Unit operation and unit processes, Mixing, Blending, Type of reactor and agitators etc.
Should have experience in handling of failure investigations: OOS, OOT, market complain, deviations.
Should have experience / knowledge of working principles of quality control instruments, HPLC, GC, XRD etc.
Should have handled Phase-I and Phase-II investigations.
Should be conversant for utilization of Minitab software and Microsoft excel for data evaluation.
Should have knowledge of report writing, technical writing and presentation skill.
Should have knowledge of relevant regulatory guidelines, ICH-Q7, ICH-Q9, USFDA OOS investigation etc..
Date: 18th March 2016 (Friday)
Time: 09:30 AM to 05:00 PM
Venue: Country Inn & Suites By Carlson
306 B, PU 4, Rusoma Circle,
Near Vijay Square,
AB Road,
Indore,
Madhya Pradesh
Contact No of HR representative: 02646-660408 / 660507
Candidates having experience of working in regulatory approved plants and possesses sound knowledge of documentation, cGMP and SAP will be preferred.
Those who are unable to attend the Personal Interview may send their resume through e-mail at ank.hr@zydusmail.com
Please mention the position applying for on the top of envelope or subject in case of e-mail.
Preference will be given to candidates having API - Pharmaceutical Industries experience.
Thank You for your information.kindly visit us: Batch Issuance Software
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