- Review and release materials for clinical trials and packaging.
- Support Quality matters in clinical packaging, storage, and distribution.
- Evaluate and improve CAPA effectiveness.
- Review and approve Change Control, Complaints, and Deviation reports.
- Monitor closure of corrective and preventive actions from audits and inspections.
- Manage and update site SOPs.
- Approve Quality Control procedures and specifications.
- Review and approve validation/qualification documents.
- Act as System Administrator for Quality-related systems.
- Perform in-process checks and inspect incoming materials.
- Review and approve batch records to ensure regulatory compliance.
- Certify batches according to guidelines.
- Release Finished Goods after packaging.
- Coordinate client audits and regulatory inspections.
- Consolidate and provide response reports for audits and inspections.
- Qualify suppliers and audit external suppliers and contractors.
- Maintain audit observation database and track responses.
- Schedule and perform internal audits.
Requirement
- Min. Diploma / degree in a related field.
- Experience in Quality Assurance, preferably in clinical packaging or pharmaceuticals.
- Has prior experence in GMP
- Strong understanding of regulatory requirements and guidelines.
- Excellent attention to detail and organizational skills.
- Ability to work independently and as part of a team.
If interested, please email me at [email protected] or telegram @alexgohhl
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Alex Goh Hock Leong
(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)
