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successfactors

Specialist - Batch Release

Gulf Pharmaceutical Industries / JULPHAR
Ras Al Khaimah, UAE
Junior · 2+ years experience
Onsite
Discovered 6 days ago

Full Job Posting

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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