Local Quality Owner – 5240 LBD

Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a Local Quality Owner on contract basis starting from 18.04.2023 until 31.12.2023 with an option of extension based in Schaffhausen, Switzerland. The function holder is responsible for QA oversight for selected parenteral products manufactured at the Schaffhausen site. This includes quality oversight for all relevant activities in sterile fill and finish, assembly and packaging of the respective combination products (if applicable).

 

Main Responsibilities:

  • On-time release of parenteral products (intermediate and finished products)
  • Proactive risk mitigation
  • Investigation lead for major non-conformances (deviations)
  • Review and approval of non-conformances (deviations) records and change control requests
  • Review and approval of GMP critical SAP master data (e. g. bill of material, manufacturing instructions etc.)
  • Review and approval of work instructions and standard operating procedures
  • Issue and review of Quality Agreements
  • Support of projects
  • Support of ‚customers‘ (production, logistics, engineering, etc.) in terms of GMP Compliance.
  • Review of Product Quality Reviews

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required
  • Master Degree in a technical or science discipline
  • Five to ten years of experience in a GMP regulated Pharma production environment or five years of experience in a relevant quality role
  • Strong background in regulatory guidelines preferred
  • Knowledge in aseptic processing preferred
  • Experience as team or project lead preferred
  • Advanced communication skills in German and English (oral and written)
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