QC Project & Equipment Project specialist.

bewerben

Job Details

zusammenfassung.

  • Branche
    Industrie
  • Kontakt
    Andreia Lourenço
  • Referenznummer
    129085-40152

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Job Details

As part of the QC Project & Equipment team , your will be able:

  • To coordinate QC activities related to outsourcing Technology transfer and/or routine analytical activities .
  • To ensure that all QC testing related to Tech Transfert are performed according to the established plan, good manufacturing practices, registration product files and site quality standards.
  • To ensure that the documentation linked to the validation is done according to defined planning to support the establishment of the APR for the commercial and clinical molecule.
  • To highlight the potential project's issue from a pro-active manner and perform troubleshooting to avoid any project delay.
  • To be the point of contact for Production, MTS, BPS, QA and others Merck sites.
  • To lead the scientific expertise in analytical and validation method at QC.
  • To apply the planning issued when appropriate.
  • To enable efficient communication with the Technology Transfer Lead, Site project manager, QC Senior Specialist, QC Associate Managers and with other relevant stakholder.
  • To contribute to the objectives and the roadmap of the department and group
  • To enable efficient communication and Strong follow up with the QC Experts to support thechnology transfers activities according to timelines agreed for during the project.

As part of the QC Project & Equipment team , your will be able:

  • To coordinate QC activities related to outsourcing Technology transfer and/or routine analytical activities .
  • To ensure that all QC testing related to Tech Transfert are performed according to the established plan, good manufacturing practices, registration product files and site quality standards.
  • To ensure that the documentation linked to the validation is done according to defined planning to support the establishment of the APR for the commercial and clinical molecule.
  • To highlight the potential project's issue from a pro-active manner and perform troubleshooting to avoid any project delay.
  • To be the point of contact for Production, MTS, BPS, QA and others Merck sites.
  • To lead the scientific expertise in analytical and validation method at QC.
  • To apply the planning issued when appropriate.
  • To enable efficient communication with the Technology Transfer Lead, Site project manager, QC Senior Specialist, QC Associate Managers and with other relevant stakholder.
  • To contribute to the objectives and the roadmap of the department and group
  • To enable efficient communication and Strong follow up with the QC Experts to support thechnology transfers activities according to timelines agreed for during the project.

  • Qualifikationen

    • Master or Eng in biology, chemistry, biotechnology or equivalent pharmaceutical experience
    • Knowledge of GMP
    • Experience in project Management (PMP, PMI, IPMA) and lab activities
    • Knowledge in analytical method, ideally in protein chemistry (Physical & Biochemistry)
    • Strong communication and diplomatic skills
    • Master computer tools: office, LIMS, Stabileo, Minitab...
    • Fluent in French and English.

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AL

Andreia Lourenço

  • Randstad Merck Aubonne

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