Officer, QMS

Amneal Pharmaceuticals • Full-time • Ahmedabad, IN • 1d ago

Description

JOB 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.

Education

QUALIFICATIONS