Senior Manager QA/RA Projects Lead

vor 4 Wochen

Neuenburg, Neuenburg, Schweiz Gi Group SA Vollzeit
Job Title: Senior Manager QA/RA Projects

We are seeking a highly 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.

Your Mission:
  • Ensure that each product is manufactured, packaged, and tested in compliance with regulatory requirements.
  • Support the site in Company Regulatory Surveillance initiatives.
  • Collaborate with the Quality Assurance team to maintain and improve Quality Systems.
Your Responsibilities:
  • Act as the deputy of the Responsible Person and Qualified Person.
  • Coordinate quality activities related to technology transfer, analytical transfer, raw materials introduction, supplier qualification, manufacturing specifications, and CMC dossier setup.
  • Conduct assessment of change controls and support response to regulatory authorities.
  • Actively support site Quality activities such as multi-site investigations, internal audits, health authority and client inspections, and continuous improvement.
Your Profile:
  • 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 related industry.
  • Solid understanding of cGMPs and regulatory requirements.
  • Excellent investigational and QA problem-solving skills.
  • Language: French and English.
Your Contact:

Manon Tenaud and Marko Durakovic

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