Working hour - Mon-Fri Office Hours
Location - Tuas
- Review and approve GMP documentation and ensure their compliance to Quality Standards (QS).
- Ensure adherence to quality procedures, regulatory requirements and GMPs.
- 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 (QS) and maintain accurate records of supplier status.
- Review and analyze the quality related issues from suppliers and recommend improvement action to mitigate compliance risk to company.
- Ensure supplier and material is qualified timeline to support production schedule.
Requirements
- Min Degree/ Diploma
- Minimum 3-5 years' experience in Quality Assurance role within the pharmaceutical industry
- Able to work within short notice
- 1 year contract
If interested, please email your resume to [email protected]
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Alex Goh Hock Leong
(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)
