Jobscope
- Review and approve GMP documentation and ensure their compliance to quality standards.
- Ensure adherence to quality procedures, regulatory requirements and eGMPs.
- Improve quality assurance systems, as necessary.
- Maintain current quality tracking systems and the quality metrics to proactively identify trends and atypical observations.
- Conduct internal audits to ensure the internal controls are effective. Conduct external audits to ensure adequate oversight to suppliers and collaborate with supplier to reduce starting material quality issues.
- Maintain inspection readiness and support inspections from regulatory agencies and customers.
- Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state.
- Support the maintenance of validated stated of GMP systems and processes.
- Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner
- Qualify and manage suppliers according to quality standards and maintain accurate records of supplier status.
- Review and analyze the quality related issues from suppliers and recommend improvement action to mitigate compliance risk
Requirements
- Diploma/ Degree in Science/ Chemical Engineering
- Quality Assurance experience with strong experience in vendor management
- Lead Audit is a must
- Pharmaceutical GMP environment will be highly preferred
All qualified applicants, please send in your resume to:
Tricia Celestine Goh (R1981653)
Recruit Express Pte Ltd | Company Reg. No. 199601303W | EA License Number: 99C459
