Description
Description:
- Manage, control, and maintain all Quality Assurance (QA) documents, records, and logs in compliance with GMP requirements.
- Ensure timely issuance, retrieval, archival, and destruction of controlled documents according to approved procedures.
- Maintain document revision history and ensure only current, approved versions are available for use.
- Coordinate document review, approval, and distribution processes with QA, Production, QC, and other departments.
- Monitor compliance with document control procedures and support internal audits and regulatory inspections.
- Maintain electronic and physical document management systems, ensuring data integrity and confidentiality.
- Track periodic review schedules for Standard Operating Procedures (SOPs), specifications, forms, and quality manuals.
- Support change control activities by updating and distributing revised documents as per approved changes.
- Prepare document control metrics, reports,



and status updates for management review.
- Ensure all documentation practices comply with applicable regulatory guidelines, including GMP, WHO, FDA, MHRA, and company quality standards.

Additional Responsibilities:
- Issue approved Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), and associated controlled documents to Production as per the production plan and document control procedures.
- Verify the completeness, correctness, and revision status of batch records before issuance, maintain issuance logs, and ensure reconciliation and retrieval of executed batch records after batch completion.

Qualifications
Education:
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred

Experience:
- 2 years or more in 2 - 5 Years

Specialized Knowledge: Licenses:

📌 Officer, QMS (Ahmedabad)
🏢 Amneal
📍 Ahmedabad