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Cleaning Validation Expert

vor 2 Monaten

Aubonne, Schweiz Randstad (Schweiz) AG Vollzeit
Jobdescription

For our client Merck in Aubonne, we are currently looking for a 'Cleaning Validation Expert' until the end of 2025.

The Cleaning validation within the Fill & Finish Department leads and manages all the cleaning validation activities within our site to ensure new production equipment and product implementation, the business continuity and Product-Lifecycle activities on legacy products portfolio, in compliance with specifications, registration and GMP requirements.

To evolve in this environment, we are looking for our next Cleaning Validation Expert (m/f/d) under a CDMAX contract until the end of 2025. 

Your role : 

  • Define and implement cleaning validation strategy in accordance with the guidelines defined on site and global level.
  • Elaborate cleaning validation operational documentation required for the successful completion of cleaning validation activities (validation plan, protocols, reports...).
  • Coordinate and execute cleaning validation activities and sampling in scope of the F&F department.
  • Reference point for cleaning validation activities within the project team.
  • Manage deviations, CAPA, Change Control within the scope of activity
  • Ensure site readiness for Health Authorities' inspection on Control Strategy and monitoring topics

Who you are : 

  • Degree in Biotechnology, Process Engineering, Pharmacy
  • Good knowledge of pharmaceuticals business, of regulatory pharmaceutical guidelines (cGMP) related issues and Health Authorities requirements
  • Good experience in cleaning validation (3-6 years)
  • Editorial quality (Procedures, risk analyses, deviations, etc.)
  • Team spirit, leadership, autonomy, proactivity, and good communication are qualities necessary for success
  • French mother tongue/fluent - Good level of English (minimum B2)
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