Specialist - Batch Release
- رأس الخيمة
- دائم
- دوام كامل
- Responsible for reviewing and auditing all completed Batch records at all process stages for all dosage forms & to ensure the conformance as per the requirement of cGMP and related SOP's
- Responsible for reviewing Batch Documents as per the related checklist of the SOP QA-00-009
- Responsible for checking the details of vendors used in the batch as per Approved vendor list.
- Responsible to update the daily tracker for the observations identified and follow up with related departments for corrections in Manufacturing/Packaging documents.
- Responsible to ensure any deviations/investigations occurred in the batch & documented the deviation/investigation details prior to entry of batch record compliance in SAP
- Responsible to provide the details of batches entered in SAP as a part of compliance at the end of the day for final release
- Responsible to issue the batch release certificate for final batch approval.
- Responsible to perform QMS actions.
- Perform any other work assigned by the Team Leader/ QA Manager.
- Must be able to manage tasks and priorities and easily adapt to changing situations
- Flexible learning abilities
- Responsible and Accountable
- Able to handle complexity at system level/ tasks level
- Advanced knowledge in cGMP
- Proven understanding and well-disciplined while dealing with all stakeholders.
- Excellent knowledge of reporting procedures and record keeping.
- Bachelor's degree in pharmacy
- 2-4 years of experience