Specialist - QA

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:

• 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 & Experience:

• 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.