To prepare and review annual product quality review data.
Initiate, review and verify the QMS documents such as change control, deviation, CAPA, laboratory and production failures investigation, LIR, market complaints, product recall, etc., and its tracking.
To prepare, review, and approve the trend of QMS activity (change control, deviation CAPA, self-inspection, OOC, and LIR.
Participates in vendor qualification and Service provider activity, Nitrosamine impurity evaluation, and review.
Coordinate training program and external laboratory audits (vendor audit), self-inspection program.
Issuance and retrieval of GMP documents of QA and cross-functional department, review document control system.
To provide the necessary support during regulatory and customer Audits
Qualifiication & Experience
B.Pharma in Any Specialization/M.Pharma in Any Specialization