Job Responsibilities
• 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
- Min Bachelor Degree in Science/Chemical Engineering/equivalent OR Diploma holder in Science/Chemical Engineering/equivalent
- Min 2-3 years of experienc in pharmaceutical industry/relevant industries
- Able to start within short notice
If interested, please email me at [email protected]
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Alex Goh Hock Leong
(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)
