Senior Manager QA/RA Projects Coordinator

Vor 4 Tagen


Neuenburg, Neuenburg, Schweiz Gi Group SA Vollzeit

Job Description:

We are seeking a highly skilled and experienced Senior Manager QA/RA Projects to join our team at Gi Life Science. As a key member of our Quality Assurance and Regulatory Affairs department, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.

About the Role:

  • Ensure the proper support of the GMP stakeholder regarding the Product's Dossier and the Regulatory Surveillance.
  • Collaborate with the other members of the QLT to ensure that the Quality Systems are maintained and improved.
  • Act as the deputy of the Responsible Person (RP) according to the Swiss Ordinance on Establishment Licenses and of the Qualified Person according to the EU Guide to Good Manufacturing Practice.

Responsibilities:

  • Act within the site's key projects teams as the 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 with relevant quality SMEs.

Requirements:

  • BSc or MSc degree in Pharmacy, Chemistry, Microbiology, or related science.
  • Minimum 7 years of experience in Quality Assurance, Quality Control, and/or Regulatory Affairs in a pharmaceutical company or other related industry.
  • Solid understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.
  • Language: French and English.

About Gi Life Science:

Gi Life Science is a leading pharmaceutical company dedicated to improving human health through innovative and high-quality products. We are committed to excellence and innovation in all aspects of our business, from research and development to manufacturing and quality control.

How to Apply:

Please submit your application, including your resume and a cover letter, to Manon Tenaud and Marko Durakovic.



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