- Perform review and release of materials, including therapeutic products intended for clinical trials and packaging components.
- Provide support on Quality matters to Project Management / Operations in the area of clinical packaging, storage and distribution.
- Evaluate CAPA effectiveness and identify process improvements.
- Review and approval of Change Control, Complaints, and Deviation reports.
- Monitor closure of corrective and preventive actions from client audit, regulatory inspections, complaints, non-conformances and deviations.
- Manage site SOP System, including review, update and approval of SOPs.
- Approve specifications, sampling instructions and other Quality Control procedures.
- Review and approval of validation/ qualification documents.
- Perform the role of a System Administrator for Quality-related Computerized Systems.
- Perform in-process checks during secondary assembly/ packaging activities and inspection of incoming materials, as required.
Requirements:
- Min Diploma or Degree in Pharmaceutical Relevant Discipline
- Prior GMP experience will be advantageous
For interested candidates, please send your most recent and updated resume to [email protected]
Subject heading: Quality Assurance Associate
Andrea Eunice Tan Min Er
(R23112594)
Recruit Express Pte Ltd
EA License No. 99C4599
