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Quality Assurance Specialist
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- Represent as in house worldwide expert in cGMP regulations and understanding phase appropriate development requirements in drug substance development process.
- Support to establish and implement company training programs regarding cGMP
- Clear understanding of the validation activities to qualify facility and equipment for GMP application
- Timely, proactively and creatively address audit /inspection findings, feedbacks and suggestions to streamline, simplify and enhance compliance programs
- PhD or MS in analytical or organic chemistry and 7+ years relevant experience preferably in analytical chemistry, API development and scale up/manufacturing, or at least 7+ years leadership position to enforce cGMP compliance and regulatory affairs
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