QC Project Specialist
vor 17 Stunden
As a key member of the QC Project team, you will be responsible for coordinating QC activities related to outsourcing technology transfer and routine analytical activities. Your primary objective will be to ensure that all QC testing related to technology transfer is performed according to established plans, good manufacturing practices, registration product files, and site quality standards.
You will be the point of contact for Production, MTS, BPS, QA, and other Merck sites, and will lead the scientific expertise in analytical and validation methods at QC. Your role will also involve applying planning issued when appropriate, enabling efficient communication with the Technology Transfer Lead, Site Project Manager, QC Senior Specialist, and other relevant stakeholders.
To be successful in this role, you will need to have a Master's or Engineer's degree in biology, chemistry, biotechnology, or equivalent pharmaceutical experience. You should also have knowledge of GMP, experience in project management (PMP, PMI, IPMA), and lab activities. Additionally, you should have strong communication and diplomatic skills, as well as fluency in French and English.
Key Responsibilities:
- Coordinate QC activities related to outsourcing technology transfer and routine analytical activities
- Ensure QC testing is performed according to established plans and good manufacturing practices
- Lead scientific expertise in analytical and validation methods at QC
- Apply planning issued when appropriate
- Enable efficient communication with stakeholders
- Contribute to department and group objectives and roadmap
Requirements:
- Master's or Engineer's degree in biology, chemistry, biotechnology, or equivalent pharmaceutical experience
- Knowledge of GMP
- Experience in project management (PMP, PMI, IPMA) and lab activities
- Strong communication and diplomatic skills
- Fluency in French and English
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