Consultant CSV (Senior Position) 100%

Job Informationen

Your Role: - Act as a CSV consultant in various IT projects in Switzerland/Germany for customers in the pharma industry. - Responsible for writing, reviewing and approving the needed documents in accordance to the customer QMS and regulatory - Support/Moderate Risk assessment sessions to help identifying risks associated to an IT system and support/monitor execution of associated mitigations. - Support testing, documentation and change management activities. - Interact with all project stakeholders (Business Owner, System Owner, Test Team) as a central project member. Capabilities: - More than 3 years experience in SW Quality Management, SW Testing, CSV or another quality assurance area within a regulated industry. - General knowledge of GxP, 21CFRPart11, Annex 11, GAMP5. Experience in other regulated domain(s) accepted as well. - Excellent communication skills, very good written and spoken English and German - Willingness to travel (up to 30%) - Experience with Test Management Tool(s) is a plus (e.g. HP ALM)

Benötigte Skills
  • Projektleitung
  • Pharma
  • Support
  • Risk Management
  • Reisetätigkeit
  • Englisch
  • Testing
Job Details
  • Pensum Vollzeit