Process Validation Expert - (m/f/d).

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The MSAT DP within the Fill & Finish Department leads and manages all the Drug Products site technical activities within our client site in Aubonne to ensure the supply of New Biologic Entities (NBEs) and 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 Process Validation Expert.

You will be responsible for:

  • Technical transfer, process validation, IMP & commercial manufacturing campaign activities coordination
  • Coordination of production troubleshooting/investigation and potential support, if required
  • Coordination with Pharmaceutical Development entities
  • Training of Aubonne site personnel
  • Internal / External audits

The MSAT DP within the Fill & Finish Department leads and manages all the Drug Products site technical activities within our client site in Aubonne to ensure the supply of New Biologic Entities (NBEs) and 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 Process Validation Expert.

You will be responsible for:

  • Technical transfer, process validation, IMP & commercial manufacturing campaign activities coordination
  • Coordination of production troubleshooting/investigation and potential support, if required
  • Coordination with Pharmaceutical Development entities
  • Training of Aubonne site personnel
  • Internal / External audits

  • qualifiche

    Who you are:

    • Degree in Biotechnology, Process Engineering, Pharmacy or related subject
    • Minimum of 3 years of experience in technology transfer, in R&D/Manufacturing environment
    • Demonstrated success record in leading projects, using project management tools and process improvements
    • Sound awareness of bio-pharmaceutical business
    • Sound awareness of GMP related issues and Health Authorities' requirements
    • Fluent in French and English

contattaci.

saremo felici di rispondere alle tue domande in merito a questa posizione.

LS

Laurène Soumahin

  • Randstad Merck Aubonne

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