QA Officer
- Vapi, Gujarat Sarigam, Gujarat
- Permanent
- Full-time
- Ensure current versions of all GMP documents are in use across departments.
- Prepare, revise, and control SOPs and related quality documents.
- Implement and enforce Good Documentation Practices (GDP).
- Prevent retention of obsolete documents in functional areas.
- Review Batch Manufacturing Records (BMR), Packing Material Records (PMR), and Raw material ,Records (RMR). Report discrepancies or abnormalities to QA Manager.
- Ensure Good Documentation practices throughout departments and plants, no obsolete document to be retained at any functional departments
- Ensure to prepare & maintain QMS for Customer complaints, Change control, deviation, NCPR, incident investigation and internal compliances.
- Conduct internal audits and maintain audit summaries and CAPA tracking. Support external audits (regulatory or customer) and ensure timely compliance.
- Support in process validation, cleaning validation, equipment qualification.
- Provide support for vendor questionnaires and customer queries and share QA-related documents as needed.
- Proper issuance and inventory management of product labels. Ensure label usage, reconciliation, and compliance.
- Support implementation of safety protocols across QA functions and plant activities. Ensure QA operations adhere to safety and regulatory standards.
- Communication Skills: Clear verbal and written communication.
- Documentation Skills: Proficient in Good Documentation Practices (GDP)
- GMP Knowledge: Sound understanding of cGMP and regulatory compliance
- Computer Skills: Proficient in MS Excel, Word, and PowerPoint.