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This position is for a highly motivated member of the Quality Control (QC) Lab at the 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 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).Perform day to day activities for the chemical laboratory which shall include testing of in- process, RM, PM and FP samples, Swab sample and Tech Transfer (as applicable).Performing the investigation of quality events assigned using root cause analysis tools defined by company procedures, maintain timelines for closure of investigations assigned and to identify and initiate CAPA's.

Education:

B.S. in Chemistry

Knowledge and Skills:

Knowledge of cGMP, Validations and Qualifications, regulatory guidelines, US Pharmacopoeias, Internal auditing, Handling of regulatory Inspections, well acquainted with QMS, well versed with Change control/deviations and market compliant management system.

LS1405559-MR_1738182056 To Apply for this Job Click Here