Julphar
Specialist - Batch Release
- Permanent
- Ras Al Khaimah, United Arab Emirates
- Experience 2 - 5 yrs
Job expiry date: 02/10/2025
Job overview
Date posted
18/08/2025
Location
Ras Al Khaimah, United Arab Emirates
Salary
Undisclosed
Compensation
Salary only
Experience
2 - 5 yrs
Seniority
Experienced
Qualification
Bachelors degree
Expiration date
02/10/2025
Job description
The Specialist - Batch Release is responsible for reviewing and auditing batch records across all dosage forms to ensure compliance with cGMP and company SOPs. The role involves verifying vendor details, managing deviations and investigations, updating compliance trackers, and entering batch compliance in SAP for final release. The specialist issues batch release certificates, performs QMS actions, and collaborates with related departments to resolve documentation issues. This position requires strong attention to detail, regulatory knowledge, and accountability in ensuring quality standards are consistently met.
Required skills
Key responsibilities
- Review and audit all completed batch records at all process stages for all dosage forms to ensure cGMP compliance
- Review batch documents as per the related checklist of SOP QA-00-009
- Check vendor details used in batches against the approved vendor list
- Update the daily tracker for observations identified and follow up with departments for corrections
- Ensure deviations or investigations in the batch are documented before batch record compliance entry in SAP
- Provide details of batches entered in SAP at the end of the day for final release
- Issue batch release certificates for final batch approval
- Perform QMS actions
- Perform other tasks as assigned by the Team Leader/QA Manager
Experience & skills
- Bachelor’s degree in Pharmacy
- 2-4 years of experience in batch release or related QA roles
- Advanced knowledge in cGMP
- Strong understanding of SOP compliance
- Knowledge of reporting procedures and record keeping
- Experience with SAP compliance entries
- Ability to manage tasks and priorities effectively
- Flexibility to adapt to changing situations
- Ability to handle complexity at system and task levels
