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26/08/2024 100% Temporary (short-term)

QC Project & Equipment Project specialist

Jobdescription

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.

Functie-eisen

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.

Andreia Lourenço