Contribute to the product development strategy within the project team and ensuring its alignment with Servier Quality Guidelines and SOPs.
Ensure management of quality risk related to the project
Quality point of contact for the project he/she is responsible for (internal & external) ...
Inform/escalade to CMC Leader and Management any quality topic which may impact his/her project
Contribute to the selection and management of CMO/CDMO
Responsible to ensure quality agreements are in place for any subcontracted activities
Contribute to provide its QA project deliverable on timely manner and in compliance with the Servier SOP (PSF, Supply Chain, specification, retest date, dossier supportive studies eg analytical validation/transfer …)
Assess any quality event associated with his/her project (Deviations, OOx, Change Control, CAPA, ...)
Contribute to product know how sharing
experience
15show more Contribute to the product development strategy within the project team and ensuring its alignment with Servier Quality Guidelines and SOPs.
Ensure management of quality risk related to the project
Quality point of contact for the project he/she is responsible for (internal & external)
Inform/escalade to CMC Leader and Management any quality topic which may impact his/her project
Contribute to the selection and management of CMO/CDMO
Responsible to ensure quality agreements are in place for any subcontracted activities
Contribute to provide its QA project deliverable on timely manner and in compliance with the Servier SOP (PSF, Supply Chain, specification, retest date, dossier supportive studies eg analytical validation/transfer …)
Assess any quality event associated with his/her project (Deviations, OOx, Change Control, CAPA, ...)
Contribute to product know how sharing
experience
15
