Position: Assoc, QA – Batch Release
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 the batch are closed before disposition.
- Impact Assessment: Assess the impact of proposed changes and provide impact assessment for batch release function.
- Discrepancy Resolution: Identify, investigate, and resolve discrepancies and non-conformities in processes, systems, or documents. Ensure impacted batches are quarantined until disposition.
- Batch Hold: Hold batches impacted by quality issues, out-of-specification results, procedural departures, or market complaints. Conduct quality investigations to determine impact, root cause, and patient safety implications.
- Non-Conformance Management: Identify batches affected by non-conformance to established quality attributes. Manage the movement and destruction of rejected batches per procedures, ensuring documentation and traceability.
- Certificates Preparation: Prepare and submit Certificates of Conformity (CoC) and Certificates of Manufacturing (CoM) as required. Verify serialization data before CoC preparation.
- Batch Shipment Control: Manage on-status batch shipment processes, ensuring necessary documents and compliance with procedures. Communicate with warehousing for batch disposition decisions.
- Reporting: Maintain a tracker and report batch release/rejection status to Supervisor/Head QA daily.
- Support PAC/RA Team: Provide quality-related information and updates to the QP and support with necessary documents.
- Regulatory Queries: Escalate regulatory/government-related queries and support authorities with necessary documentation and updates.
- Compliance Initiatives: Support compliance and quality initiatives to ensure continuous site compliance.
Additional Information:
- Experience: 4-7 years
- Qualification: M.Pharm, B.Pharm, M.Sc
- Location: Ahmedabad, Gujarat
- Industry Type: Pharma/Healthcare/Clinical research
- Functional Area: QA
- Application End Date: 20th August 2024
If you are interested in applying for this position or need further details, please ensure you meet the qualifications and experience requirements, and prepare your application before the closing date.
