Specialist - Batch Release
Role Overview
Review and audit completed pharmaceutical manufacturing and packaging batch records across dosage forms to ensure compliance before release.
The role includes vendor verification, tracking documentation observations, coordinating corrections, updating batch status in SAP and issuing release certificates.
Key Skills for This Role
Full Job Posting
Role overview
Review and audit completed pharmaceutical manufacturing and packaging batch records across dosage forms to ensure compliance before release.
The role includes vendor verification, tracking documentation observations, coordinating corrections, updating batch status in SAP and issuing release certificates.
Batch release responsibilities
- Review batch records at all process stages for compliance with cGMP requirements and applicable SOPs.
- Review batch documentation using the checklist in SOP QA-00-009.
- Verify vendors used in batches against the Approved Vendor List.
- Track documentation observations and coordinate timely correction of manufacturing and packaging deficiencies.
- Confirm deviations and investigations are documented before updating batch compliance status in SAP.
- Provide daily updates on batches in SAP for compliance review and final release; issue Batch Release Certificates after approval.
- Perform assigned QMS activities and other duties as directed by the Team Leader or QA Manager.
Education and experience
- At least two years of experience in the pharmaceutical industry.
- Bachelor’s degree in Pharmacy.
- Advanced knowledge of cGMP.
- Well-disciplined stakeholder engagement and understanding of stakeholder dealings.
- Excellent knowledge of reporting procedures and record keeping.
About Julphar
A UAE public pharmaceutical manufacturer producing generic and in-licensed medicines for patients across MENA markets.
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