Senior Manager Quality Assurance and Regulatory Projects
Vor 6 Tagen
Gi Life Science is seeking a highly skilled Senior Manager to lead their QA/RA projects.
About the Role:The successful candidate will be responsible for ensuring that all products are manufactured, packaged, and tested in compliance with regulatory requirements. This includes supporting the site in Company Regulatory Surveillance initiatives and maintaining quality systems.
Key Responsibilities:
- Act as deputy to the Responsible Person (RP) and Qualified Person
- Main Quality representative and single point of contact for QA, Compliance, Quality Supplier, and Regulatory Affairs
- Coordinate and drive quality activities related to technology transfer, analytical tech transfer, raw materials introduction, supplier qualification, manufacturing specifications, and CMC dossier set up
- Conduct assessment of change controls for site-related projects and/or for product life-cycle projects
- Support response related to regulatory authorities requests
To be successful in this role, you will need:
- BSc or MSc degree in Pharmacy, Chemistry, Microbiology or related science
- Minimum 7 years of experience in Quality Assurance, Quality Control, and/or Regulatory Affair in a pharmaceutical company or other related industry
- Solid understanding of cGMPs and Swiss, EU, and FDA regulatory requirements
- Solid knowledge of Oral Solid Dosage form manufacturing, packaging, testing, warehousing processes, validation, and registration
You will also possess excellent investigational and QA problem-solving skills and fluency in French and English.
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