Walkin Interview for Quality Control at Cadila Pharmaceuticals Ltd (API) @ Ankleshwar Walkin Date : 14.05.2016 Time : 2:30 - 5.00 pm.

Walkin Interview for Quality Control
at Cadila Pharmaceuticals Ltd (API)  @ Ankleshwar




Walkin Date : 14.05.2016


Time : 2:30 - 5.00 pm.




Venue: Cadila Pharmaceuticals Ltd. Plot No.294 

Opp. Atul Ltd GIDC Ankleshwar, Dist.:Bharuch, Gujarat




Position :  Officer / Executive / AM


Qualification: B.Sc. / M.Sc. / B. Pharm / M. Pharm


Experience  : 2 to 10 Years in pharmaceuticals (API) organisation and have sound knowledge of QC activities.




Job Profile:
1.  To maintain and adherence of the GLP and safety procedures in laboratory.


2.  To raise the request for issuance of work data sheet / protocols.
Perform sampling of raw materials / Packing materials / intermediates and finish products as per laid down procedure.


3.  To perform the analysis as per work allocation and records the results in work sheet / protocol and maintain on line documentation.


4.  To work as Analyst / Operator as a level of users and maintain the CFR 21 part -11 compliance by following laid down procedures.


5.  To perform analysis of In-process, intermediate, finished products & returned goods / raw materials Hold time / Stability study /reference / working standard analysis as per laid down specification & test procedures , SOPs, as per work allocation and report the analysis data in LIMS modules and report to Section Head / Or QC head.


6.  To ensure that every specification and method of analysis used of right product/material code.


7.  To follow the instruction of Shift /Section In charge for analysis /planning.


8.  To report any incidents / Deviation/ discrepancy in laboratory analysis to QC- In charge.
Responsible for performing calibration of laboratory instruments as per schedule and laid down SOPs with documentation and updation of instrument calibration status tag.


9.  To record and ensure all the entries, and results are in line with current specifications and STPs.


10.              To prepare standard operating procedures, work data sheets and other documents related to QC.


11.              To ensure the all column performance and column entry are maintain in column logbooks.


12.              To maintain instruments log books properly as per analysis.


13.              To acquire training from concerned person to update the cGMP system update technical knowledge.


14.              To record analytical data in work data sheets / protocols for raw material / packing materials/intermediates /APIs and etc.. as per current specification and method of analysis.
Preparation, qualification and management of working standard for Raw materials Intermediates/APIs.
15.              Responsible for planning of HPLC related analysis data and analysis of data generated through LIMS & SAP systems / modules .


16.              To ensure that the all the analysis performed in HPLC section is as per SOP and current specification and test procedures.


17.              To ensure all HPLC are working satisfactory. If some problem in system then try to resolve in consultation with service engineer.


18.              To maintain reference / working standard/impurity standard usage records.
19.              Review of in-process analysis data and approval for further processing of the batch.
20.              To maintain instrument history record.
21.              Joint analysis with R&D personnel during analytical method transfer on GC.
22.              Preparation of stability protocols and stability reports.
23.              To perform analysis of stability samples as per stability schedule
24.              Daily monitoring and recording of temperature and humidity of refrigerator / working standard chamber and laboratory area.
25.              Perform holding time study of intermediates and preparation of reports.
26.              To prepare/ check the protocols & reports for analytical method validation and analytical method transfer
27.              Inform and Investigate OOS results in RM/Intermediates/APIs


28.              Initiation of change control / deviations / NQI / OOT related to QC.
29.              Ensure CFR 21 part -11 compliance and follow good chromatography practices during analysis, integration and reviewing of on line and off  
  


 Contact Person : Mayur Dalal (8238070120)