Quality Assurance Associate
24 hours ago
We are seeking a highly skilled Quality Assurance Associate to join our team at RECRUIT EXPRESS PTE LTD. The successful candidate will be responsible for ensuring the quality and compliance of our pharmaceutical products and processes.
Key Responsibilities- Quality Assurance and Compliance
- 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.
- Quality Management and Control
- 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.
- Process Improvement and Quality Assurance
- Perform in-process checks during secondary assembly/ packaging activities and inspection of incoming materials, as required.
- Min Diploma or Degree in Pharmaceutical Relevant Discipline
- Prior GMP experience will be advantageous
- Sampling
- CAPA
- Quality Control
- Quality Management
- Quality Assurance
- Quality System
- Interpersonal Skills
- ISO
- GMP
- Clinical Trials
- Defect Tracking
- Compliance
- Project Management
- Packaging
- Change Control
- Assembly
- Manufacturing
- Able To Work Independently
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