Specialist - QA
Role Overview
The position ensures manufacturing and packaging operations meet cGMP, SOP, and product requirements through shop-floor quality oversight, accurate batch documentation, and effective quality issue handling.
Key Skills for This Role
Full Job Posting
Role Overview
The position ensures manufacturing and packaging operations meet cGMP, SOP, and product requirements through shop-floor quality oversight, accurate batch documentation, and effective quality issue handling.
Responsibilities
- Perform line clearance and release activities and timely in-process checks during manufacturing and packaging.
- Verify materials and components, gowning, cleanliness, environmental conditions, and calibration of in-process equipment.
- Document and verify results; maintain traceable batch records, logbooks, and labels; review SOPs, BMRs, and BPRs.
- Investigate deviations and market complaints; manage CAPA and change control reports in Ampelogic.
- Prepare Annual Product Quality Reviews.
- Support audits and audit readiness, site gap assessments, GEMBA walks, and sampling adherence follow-up.
- Conduct facility and process quality risk assessments.
- Follow environmental, health, and safety requirements, use appropriate PPE, and contribute to risk reduction and continual improvement.
Education & Experience
- Bachelor's degree in Pharmacy, Science, or Chemical Engineering.
- At least 3 years of experience in quality operations or manufacturing.
- Knowledge of GMP, SOPs, batch records, and Quality Management Systems.
- Good computer skills and English proficiency.
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