To provide quality support to the Clinical Storage and Distribution facility in Singapore in line with PIC/S Good Manufacturing Practice and Good Distribution Practice. (GMP and GDP)
SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES
General :
- 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.
Authorized Person Responsibility:
- 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.
Audits:
- 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.
Requirements
- Min Diploma / Degree in any science / engineering courses
- Min 2 to 3 years of quality experience in pharma / medical device manufacturing / clinical storage industry
Salary range: $3.5K to $4.2K
Office Hours
Interested candidates, please forward your resume to [email protected]
Consultant: Huang Jingsheng Kevyn (R1333338)
Recruit Express Pte Ltd (99C4599)
