QA skilled to manage Document Management System (DMS), Training Management System (TMS), and routine QA compliance activities. The role requires solid GMP knowledge and strong documentation skills.
Key Responsibilities
- Manage controlled documents in the DMS (review, issuance, archival).
- Maintain the document cell, ensure proper document storage, controlled access, and easy retrieval.
- Track document inventory (SOPs, formats, logbooks) and ensure timely issuance and replacement of revised versions.
- Maintain training matrices and verify training records for all employees, including new joinees.
- Coordinate with cross‑functional teams to resolve document and training gaps.
- Ensure compliance with GMP, GDP, and ALCOA+ requirements.
Skills Required
- Strong understanding of GMP and data integrity.
- Excellent communication, coordination, and documentation skills.
Education
- B.Pharm / M.Pharm / M.Sc (Biotech/Microbiology or related field)
Qualifications
B.Pharm / M.Pharm / M.Sc (Biotech/Microbiology or related field)