Jobdescription
As part of the QC Project & Equipment team ,your will be able:
* To coordinate QCactivities related to outsourcing Technology transfer and/orroutine analytical activities .
* To ensure thatall QC testing related to Tech Transfert are performed according tothe established plan, good manufacturing practices, registrationproduct files and site quality standards.
* Toensure that the documentation linked to the validation is doneaccording to defined planning to support the establishment of theAPR for the commercial and clinicalmolecule.
* To highlight the potential project'sissue from a pro-active manner and perform troubleshooting to avoidany project delay.
* To be the point of contactfor Production, MTS, BPS, QA and others Mercksites.
* To lead the scientific expertise inanalytical and validation method at QC.
* Toapply the planning issued when appropriate.
* Toenable efficient communication with the Technology Transfer Lead,Site project manager, QC Senior Specialist, QC Associate Managersand with other relevant stakholder.
* Tocontribute to the objectives and the roadmap of the department andgroup
* To enable efficient communication andStrong follow up with the QC Experts to support thechnologytransfers activities according to timelines agreed for during theproject.
Qualifikationen
* Master or Eng in biology, chemistry,biotechnology or equivalent pharmaceuticalexperience
* Knowledge ofGMP
* Experience in project Management (PMP, PMI,IPMA) and lab activities
* Knowledge inanalytical method, ideally in protein chemistry (Physical &Biochemistry)
* Strong communication anddiplomatic skills
* Master computer tools:office, LIMS, Stabileo, Minitab...
* Fluent inFrench and English.