June 11, 2023
May 14, 2024
- 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.