Job Scope:
- Review and approve GMP documentation and ensure their compliance to Quality Standards (PQS).
- Ensure adherence to quality procedures, regulatory requirements and cGMPs.
- 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 suppmt 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 (PQS) and maintain accurate records of supplier status. Review and analyze the quality related issues from suppliers and recommend improvement action to mitigate compliance risk.
- Ensure supplier and material is qualified timeline to support production schedule.
Requirement:
- Bachelor Degree / Diploma in Science/Chemical Engineering or equivalent
If you are interested in exploring this role or other current openings in the market, kindly email me at [email protected] with your resume.
We regret to inform that only shortlisted candidates will be notified.
Ashley Loo Yan Ni | R2095115 | EA License Number: 99C4599
Recruit Express Pte Ltd Company Reg. No. 199601303W
