- 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.
Required Skills:
- Communication Skills: Clear verbal and written communication.
- Documentation Skills: Proficient in Positive Documentation Practices (GDP)
- GMP Knowledge: Sound understanding of cGMP and regulatory compliance
- Computer Skills: Proficient in MS Excel, Word, and PowerPoint.
Required Qualification: - M.Sc - Chemistry
Salary :- Upto 5.50 LPA
If you are interested for this opening please send updated resume on same mail with following details.
Total No. of Years Experience :-
Current CTC :-
Expected CTC :-
Notice Period :-
📌 QA Officer (Vapi)
🏢 Quality HR India
📍 Vapi
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