Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules – both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA is a fast growing and robust US generics business, with plans to move into the innovative market as well.
POSITION SUMMARY:
This position is for a highly motivated member of the Quality Control (QC) Lab at the Monroe manufacturing facility, reporting to the QC Manager. Primary responsibilities for this position will be: perform QC analysis in compliance to cGMP in line with standards prescribed by USFDA. Maintain compliance to data integrity and cGMP in QC lab in line with standards prescribed by USFDA. Perform IOQ/Calibration for instruments in QC lab at Monroe with guidance of CQA. Execute and complete procedures and systems for RM, PM, FD and in process testing in QC lab. Provide information, data for evaluation and execution of stability study as per Quality and regulatory requirement. Timely complete testing and ensure compliance during analytical TT and AMV performed in QC lab. Able to be a qualified trainer for QC related systems and SOP’s and responsible that personnel are appropriately trained. As a member of Site Investigation Team (SIT) needs to investigate quality events and perform Root Cause Analysis (RCA).
OVERALL JOB RESPONSIBILITIES:
Education :
A minimum of a Bachelor’s degree in Chemistry / Pharmaceutical Sciences or Equivalent.
Experience:
• 4+ years in the field of Pharmaceutical (manufacturing facility).
• Background in the functional areas of Quality Control in Stability, Finished Goods and some Raw Materials with a some experience in Analytical R&D.
Extensive knowledge in general laboratory equipment including but not limited to: GC, HPLC, Polarography, Particulate Matter, UV-Vis and FTIR
Knowledge and Skill:
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