Description

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.

  
  

  qualifications

  • 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.