Job Post: Associate, QA – Batch Release
Job Description:
- Review executed Batch Manufacturing Records and Batch Packing Records.
- Ensure accuracy, completeness, and compliance with established specifications in batch records for release or reject determination.
- Review batch records and data against applicable Technical Package, SOPs, specifications, GDPs, GMPs, and quality parameters.
- Address abnormalities observed during batch records review in coordination with respective functions.
- Ensure completion and closure of investigations associated with batch records review prior to batch disposition.
- Prepare Batch Release Note for compliant batches and Batch Rejection Note for non-compliant batches.
- Apply appropriate batch labeling for rejected batches and oversee their relocation in the warehouse.
- Ensure adherence to current Good Manufacturing Practice (cGMP) standards.
- Issue and generate rejected labels for non-conforming batches.
10. Periodically verify reject label audit trail report; report discrepancies to Supervisor. Additional Responsibilities:
- Prepare change control management (CCM) or document change request (DCR) for Batch Release activities.
- Raise Non-conformance Reports (NCR) for any non-compliance during Batch Release activities.
- Prepare, review, or revise SOPs as needed to meet regulatory requirements or address internal audit observations.
- Prepare Certificate of Conformity and Certificate of Manufacturing; submit to PAC/partner as required.
- Coordinate with PAC team for QP-related query support as per standard operating procedure.
- Support cross-functional staff in resolving Batch records related queries.
- Initiate and implement corrective and preventive actions in coordination with respective functions.
- Perform execution tasks for Corrective Action, Preventive Action, and Change Control Management.
- Submit Batch Release documents to IRA as required; keep supervisor informed of submission status.
- Provide entry access to QA office and retain sample room; maintain related documents.
Additional Information:
- Experience: 2 to 6 years
- Qualification: M.Pharm, B.Pharm, M.Sc
- Location: Ahmedabad, Gujarat
- Industry Type: Pharma/ Healthcare/ Clinical Research
- Functional Area: QA
- End Date: 30th January 2024
How to Apply:
Interested candidates meeting the qualifications can submit their resumes to [email@example.com] by the closing date. Please mention “Associate, QA – Batch Release” in the subject line.
Note: Only shortlisted candidates will be contacted for further assessment.
This job post is designed to attract qualified candidates while providing a clear outline of the responsibilities and requirements for the position.
