Job Title: Associate, QA – Batch Release
Location: Ahmedabad, Gujarat
Industry: Pharma/Healthcare/Clinical Research
Experience Required: 4-7 years
Qualification: M.Pharm, B.Pharm, M.Sc
End Date: 20th August 2024
Job Description
- Batch Disposition: Review batch manufacturing, packing, and testing records to ensure compliance with SOPs, specifications, and standard formats. Ensure all investigations related to batches are closed prior to batch disposition.
- Change Impact Assessment: Evaluate the impact of proposed changes for batch release, providing impact assessments for change proposals.
- Discrepancy Resolution: Identify, investigate, and resolve discrepancies and non-conformities in processes, systems, or documents. Quarantine impacted batches until disposition.
- Batch Hold Management: Place batches on hold if impacted by quality issues, out-of-specification results, procedural deviations, or market complaints. Conduct investigations to determine the impact, root cause, and patient safety implications.
- Non-Conformance Handling: Identify batches with non-conformance to quality attributes, move them to the rejected area, and ensure their destruction as per established procedures. Reconcile batch and packaging materials with documentation and traceability.
- Certificate Preparation: Prepare and submit Certificate of Conformity (CoC) and Certificate of Manufacturing (CoM) as required by Quality and Business Development. Ensure serialization data verification in EMVs is completed before CoC preparation.
- Batch Shipment Control: Oversee on-status batch shipments, ensuring compliance with procedures and coordinating with warehousing for batch disposition decisions.
- Reporting: Maintain a tracker and report batch release/rejection status to the Supervisor/Head QA daily.
- Support to PAC/RA Team: Assist the PAC/RA team with quality-related queries, updates to QP, and provide necessary documentation and data.
- Regulatory Support: Escalate regulatory/Government queries and support authorities with required documentation and updates for released products.
- Compliance Support: Ensure continuous compliance with manufacturing and release standards by supporting all quality-related initiatives.
Additional Information
- Functional Area: QA
- Global Impact: Baxter’s broad portfolio of essential renal and hospital products enhances healthcare access worldwide.
- Join Us: Be part of a global team dedicated to critical healthcare solutions.
For more details and to apply, please submit your application by 20th August 2024.
