Well-versed with the cGMP (current Good Manufacturing Practices) and regulatory requirements as per the Drugs & Cosmetics Act, Schedule M, and WHO guidelines.
Serve as a primary operational quality interface that acts as a liaison between Abbott and TPM to ensure products are manufactured following cGMP standards.
Strong knowledge of GLP and review of analytical data of the raw material, finished product, and stability sample analysis.
Acquainted with periodic Pharmacopoeial updates related to raw material & finished products and their compliance.
Should be independently able to conduct Investigations of market complaints, and product failures, and understand RCA and CAPA processes.
Should be able to independently evaluate quality documents like Change control, Deviation, OOS, Failures, Incidents, APQR, batch records, etc.
Verify product manufacturing process, line clearance, in-process checks, and AQL procedures at different processing stages.
Should have knowledge of analytical method transfer and technology transfer, Process validation, hold time study & stability study.
Well-versed with requirements related to Aseptic area technics, Water systems, environment monitoring, preventive maintenance, calibration, routine qualification of systems, and self-inspection.
Understands and applies basic Risk Management principles.
Education & Experience:
Science / Pharmacy Graduate with 10+ years of experience in the pharmaceutical industry.
Incumbent having experience in manufacturing quality operations, well versed with market complaints, CAPA, Change Control, etc.
