Preparation, review, issuance, and archival of GMP documents such as SOPs, BMRs, BPRs, protocols, and logbooks.
Ensure controlled documentation practices in compliance with regulatory guidelines (cGMP, WHO, USFDA, etc.).
Maintain and update document control systems; ensure timely revision and retrieval of documents.
Coordinate with production, QC, and QA teams for documentation needs and change control activities.
Handle internal and external audit documentation requests and ensure readiness.
Maintain master document list and track issuance and retrieval status.
Desired Skills:
Sound understanding of documentation practices in API manufacturing.
Knowledge of cGMP, ICH, and regulatory guidelines.
Proficient in MS Office tools; strong attention to detail and record-keeping.
Job Types: Full-time, Permanent
Pay: ₹20,000.00 - ₹35,000.00 per month
Benefits:
Health insurance
Provident Fund
Work Location: In person
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