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Senior GMP Auditor for Biologics in Basel

vor 2 Wochen


Basel, Basel-Stadt, Schweiz TN Switzerland Vollzeit

About the Role:

Senior GMP Auditor for Biologics in Basel

TN Switzerland is seeking a Senior GMP Auditor to join our team. The successful candidate will have experience with HA and CMO auditing on GMP/GDP/GLP standards, as well as lead auditor experience.

The ideal candidate will have a BSc/MSc in Life Sciences, 10 years of experience from the pharmaceutical industry with GMP/GDP experience, and be self-assured and confident with a strong personality.

Key Responsibilities:

  • Support the strategic development of an effective global risk-based audit strategy
  • Plan, lead, conduct, document, and follow-up of assigned GMP/GDP audits as Lead Auditor
  • Manage Global, Regional, and Affiliate internal audits/self-inspections
  • Manage external audits of CMOs, CLOs, contract service providers and suppliers
  • Provide regulatory guidance for timely remediation and recommendations of proposed filings

Your Profile:

  • BSc/MSc in Life Sciences
  • 10 years experience from the pharmaceutical industry with GMP/GDP experience
  • Experience with HA and CMO auditing on GMP/GDP/GLP standards
  • Self-assured and confident personality with Lead Auditor experience

About Us:

TN Switzerland is an innovative international biopharmaceutical company with offices in Basel. We are focused on late-stage research and development, patient access and commercialization, and put a strong emphasis on building trustful and effective relationships throughout all steps in the multi-site supply network.