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Specialist QA - QMS

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23/07/2024 100% Temporaire / intérim
Randstad (Schweiz) AG
Specialist QA - QMS
Jobdescription

To join a dynamic Global QA team in vaud canton, we're looking for a Specialist QA - QMS candidate to support the QA oversight for EU functions and country affiliates worldwide. 

Temporary position of 6 months - maternity cover leave
Based in Lausanne 

RESPONSIBILITIES

  • Provide operational QA support for the implementation and maintenance of GxP QMS for country affiliates.
  • Support QA operations for EU GxP functions in QMS development.
  • Assist in improving the GxP QMS within the QA team.
GxP QMS Affiliate QA Activities:
  • Deliver operational QA support for the implementation, improvement, and maintenance of Country Affiliate QMS, including SOP review, eDMS implementation, and procedural document updates.
  • Participate in developing Quality Metrics/Dashboard for GxP areas, including timely management of training reports and dashboards, and handling training matrices for country affiliates.
  • Provide operational QA support for various EU GxP functions (Medical Affairs, Public Affairs, Clinical teams, etc.) in QMS development as needed.
  • Assist in implementing and maintaining the Quality Management System, including support for change control and deviations, ensuring continuous process improvement.

PROFILE

  • A Bachelor's degree in a science or healthcare-related field.
  • 1 to 3 years of experience in a pharmaceutical or biopharmaceutical company in a QA or QMS role, focusing on training management, SOP implementation, deviation management, and change control.
  • Experience with Veeva eDMS, eLMS, and eQMS
  • Experience as local QA for a country affiliate/subsidiary or in Clinical, Pharmacovigilance, or Medical Affairs is a plus.
  • Fluency in written and spoken English (company language); knowledge of another language like French is an asset.
Margot Ferraton

À propos de l'entreprise

3,8 (150 évaluations)