- Review and ensure compliance with GMP, GLP, SOPs and regulatory requirements.
- Review Batch Manufacturing Records (BMR), Batch Packing Records (BPR) and other manufacturing documents.
- Perform in-process and shop-floor QA activities.
- Ensure proper documentation and data integrity as per ALCOA+ principles.
- Review and monitor deviations, CAPA, change controls and incidents.
- Assist in internal audits, customer audits and regulatory inspections.
- Verify implementation of approved SOPs and quality procedures.
- Review and approve logbooks, formats, specifications and other QA documents.
- Coordinate with Production, QC, Warehouse and other departments for quality-related activities.
- Monitor cleanliness, hygiene and GMP compliance in manufacturing and other areas.
- Support qualification/validation activities and review related documents.
- Identify quality risks and ensure timely corrective and preventive actions.
- Maintain proper QA records and prepare quality-related reports.
- Ensure compliance with company quality policies and applicable regulatory guidelines.
Required Skills:
- Good knowledge of GMP and pharmaceutical QA practices.
- Good documentation and communication skills.
- Knowledge of deviation, CAPA and change control.
- Ability to work independently and coordinate with cross-functional teams.
- Good attention to detail and problem-solving ability.
Pay: ₹240,000.00 - ₹300,000.00 per year
Advantages:
- Health insurance
- Life insurance
- Provident Fund