Validation and Compliance Expert

Vor 5 Tagen


Lausanne, Waadt, Schweiz Incyte Vollzeit

At Debiopharm International SA, we pride ourselves on being a leader in the biopharmaceutical industry. Our team is dedicated to developing innovative therapies for patients with oncology and infectious diseases, and we are seeking a skilled CSV Senior Officer to join our Quality Management organization in Lausanne.

You will play a vital role in contributing to the development of pioneering treatments in Oncology & Anti-infectives by supporting the Computerized Systems Validation (CSV) Lead in endorsing, maintaining, and facilitating the appropriate compliance level for CSV activities.

Your responsibilities will include:

  • Driving compliance excellence with GxP standards and internal quality guidelines.
  • Collaborating with the CSV Lead, Business Process Owner, and System Owner to create synergy between business, Quality, and IT.
  • Representing Quality during inspections, audits, or other inquiries on CSV matters.
  • Overseeing vendor documentation, ensuring vendor compliance.
  • Creating and approving CSV deliverables, and ensuring proper filing in document management systems.

To excel in this role, you will need to possess excellent analytical thinking and problem-solving skills, as well as strong interpersonal communication skills.



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