Senior Scientist Regulatory Compliance (m/f/d)

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Update day: 04-04-2024

Location: Zürich Zürich ZH

Category: Pharmaceutical / Chemical / Biotech

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We are currently assisting our client in their search to hire an experienced Senior Scientist (m/f) in Bern, who will assist the Regulatory Compliance team


Main responsibilities:

  • Authority- and customer inspections at the Bern site • Preparation of GMP documents for regulatory submissions
  • Responses to questions from regulators
  • Coordination, performance and follow-up of paper based GMP inspections
  • Preparation of GMP-certificate renewal and tender relevant documentation based on request by Affiliates
  • Change Management: Ensuring timely implementation of Regulatory Compliance related actions
  • Supporting answers to Regulatory Compliance related questions from internal or external
  • Perform Ad-Hoc duties in specialized field
  • Participation in predetermined trainings
  • Compliant performance of activities after appropriate training


Qualifications:

  • University degree or university of applied sciences degree in natural sciences (e.g. Biology, Chemistry or Pharmacy)
  • Experience in Quality or manufacturing in a pharmaceutical GMP environment
  • Experience with management of Audits is required
  • Experienced in reading regulations
  • Demonstrated communication skills
  • Demonstrated interest for technical processes
  • Demonstrated German and English skills (written and spoken)
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Deadline: 19-05-2024

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