Batch Release Specialist
Julphar · Ras Al Khaimah
Job description
About the role
Julphar is hiring a full-time Batch Release Specialist in Ras Al Khaimah. The role reviews and audits completed manufacturing and packaging batch records across all dosage forms to ensure compliance with cGMP requirements and approved SOPs, and supports batch release and quality management system activities.
Key responsibilities
- Review and audit completed batch records at all process stages across all dosage forms, using the checklist in SOP QA-00-009
- Verify that all vendors used in a batch are on the Approved Vendor List
- Maintain and update a daily tracker of observations and coordinate with departments to correct deficiencies in manufacturing and packaging documentation
- Ensure batch deviations and investigations are documented before updating batch compliance status in SAP
- Provide daily updates on batches entered into SAP for compliance review and final release
- Issue Batch Release Certificates after final batch approval
- Perform assigned QMS activities and other duties assigned by the Team Leader or QA Manager
Required profile
- Minimum 2 years of experience in the pharmaceutical industry
- Bachelor's degree in Pharmacy
- Proven understanding of cGMP and excellent knowledge of reporting procedures and record keeping
- Well-disciplined approach when dealing with all stakeholders
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Published 2 weeks ago
Expires 1 month from now
30 views · 0 interested
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Julphar
Ras Al Khaimah