Quality Manager
1 week ago
We are seeking an experienced QA professional to join our team as an Advanced QA Professional. The ideal candidate will possess a strong understanding of GMP regulations and quality assurance principles, as well as excellent communication and interpersonal skills.
The successful candidate will be responsible for ensuring best-in-class quality assurance in the qualification of facilities and equipment used for GMP production of APIs for clinical studies. This includes close collaboration with scientists in the API Pilot production and QA colleagues across functions.
Your key responsibilities will include:
- Identifying and contributing to strengthening the compliance level of our production facilities, acting as a trusted consultant and applying a strong QA mindset.
- Contributing to resolving ad-hoc questions and complexities related to GMP compliance.
- Approving documentation for the qualification of facilities and equipment, as well as other supporting documents for the Pilot facilities.
- Overseeing validation activities, handling deviations, managing change requests, overseeing cleaning, and providing QA presence in production.
- Evaluating requirements and setting the quality direction for the API Pilot production and related projects.
You will have the opportunity to work with a diverse team of professionals and contribute to the development of our company's quality management system.
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