Specialist - QA
Julphar
Date: 2 weeks ago
City: Ras al-Khaimah
Contract type: Full time
Job Role
The position is responsible for ensuring manufacturing and packaging operations meet cGMP, SOP and product requirements through shop-floor quality oversight, accurate batch documentation and effective handling of quality issues.
Responsibilities
The position is responsible for ensuring manufacturing and packaging operations meet cGMP, SOP and product requirements through shop-floor quality oversight, accurate batch documentation and effective handling of quality issues.
Responsibilities
- Perform line clearance and release activities, and timely in-process checks during manufacturing and packaging.
- Verify correct materials/components, gowning, cleanliness, environmental conditions and calibration of in-process equipment.
- Document and verify results; maintain traceable, accurate batch records, logbooks and labels. Review SOPs, batch manufacturing records (BMRs) and batch packaging records (BPRs).
- Investigate deviations and market complaints. Manage corrective and preventive actions (CAPA) and change control reports (CCR) in Ampelogic.
- Prepare Annual Product Quality Reviews (APQR); support audits and audit readiness, site gap assessments, GEMBA walks, sampling adherence follow-up and facility/process quality risk assessments.
- Follow environmental, health and safety requirements, use appropriate PPE and contribute to risk reduction and continual improvement.
- Education: Bachelor's degree in Pharmacy, Science or Chemical Engineering.
- Experience: 3+ years in quality operations or manufacturing.
- Knowledge: GMP, SOPs, batch records and Quality Management Systems (QMS); good computer skills and English proficiency.
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