Review and audit completed manufacturing and packaging batch records across all dosage forms to ensure compliance with cGMP requirements and approved SOPs. Verify vendors against the approved vendor list, track documentation observations, and coordinate corrective actions with relevant departments. Ensure batch deviations and investigations are properly documented before updating batch compliance status in SAP. Provide daily batch compliance updates for final release, issue batch release certificates, and execute relevant Quality Management System (QMS) activities.
Responsibilities:
- Responsible for reviewing and auditing completed batch records at all process stages across all dosage forms to ensure compliance with cGMP requirements and applicable SOPs.
- Review batch documentation in accordance with the checklist specified in SOP QA-00-009.
- Verify that all vendors used in the batch are included in the Approved Vendor List.
- Maintain and update the daily tracker of identified observations and coordinate with the relevant departments to ensure timely correction of deficiencies in manufacturing and packaging documentation.
- Ensure that all batch deviations and investigations are properly documented before updating batch record compliance status in SAP.
- Provide daily updates on batches entered into SAP for compliance review and final batch release.
- Issue Batch Release Certificates following final batch approval.
- Perform assigned Quality Management System (QMS) activities in accordance with established procedures.
- Perform any other duties assigned by the Team Leader or QA Manager.
Education & Experience:
- 2 Years of minimum experience in Pharmaceutical industry.
- Bachelor’s degree in Pharmacy
- Advanced knowledge in cGMP
- Proven understanding and well-disciplined while dealing with all stakeholders.
- Excellent knowledge of reporting procedures and record keeping.
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