- 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.
- Perform review and approval of batch records (pre-execution and post-execution) to ensure compliance with applicable regulations and guidelines.
- Perform batch certification in accordance with the principles detailed in Annex 16 of the PIC/S GMP Guide, and any other applicable guidelines or regulations.
- Perform release of Finished Goods (after secondary assembly/ packaging activities).
- Coordinate client audits and regulatory inspections.
- Ensure timely consolidation and provision of response reports for client audits and regulatory inspections.
- Perform supplier qualification, including audit of external suppliers and contractors.
- Maintain external/internal audit observation database and track observation response through to closure including a review of the corrective actions taken.
- Schedule and perform internal audits as per audit plan.
Requirements
- Minimally a diploma
- prior experience in GMP is preferred
Interested and qualified candidates, please send in your application to [email protected]
Ivy Yong Shi Mei
R2198995
Recruit Express Pte Ltd 99C4599
