My client is a global name in the design and manufacturing of complex products and now seek an experienced QA Manager focusing on MicroArrays
- Ensure processes are established and performed in compliance to regulatory, ISO and quality standards
- Review and approve validation protocols for product and process changes.
- Ensure failure investigations are performed and well documented for non-conforming materials and products.
- Establish and maintain database to track root cause, disposition, and cost for non-conforming material.
- Identify quality issues through data and trend analysis, work with relevant functions on corrective and preventive actions.
- Lead internal/external audit teams to ensure compliance to quality and regulatory requirements.
- Apply advanced principles and concepts to the development and enhancement of processes.
- Apply unique knowledge and employ autonomous judgment in selecting creative techniques to resolve complex problem
- Advanced Degree in Science, Engineering with at least 12 years' experience in QA from pharma/biotech
- Experience with precision engineering technology/etching/lithography will be a plus
- Knowledge of GMP principles
- Ability to use quality tools - trend, regression charts
- Fundamental knowledge of quality and regulatory standards
Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).