QM Support Manager IMP (m/f)

REFERENZNUMMER:

372976/11

IHRE AUFGABEN:

-Support the IMP Quality Management
-Responsibility for the lot disposition (release or reject) of IMPs (= Investigational Medicinal Products)
-Support the authorization to sign release certificates and the right to reject IMPs that are not conforming to specifications or that were not produced in accordance with GMP and Swiss Law Requirements
-Assurance that the quality of the produced IMPs is in accordance with the Swissmedic
-Participation in compiling, reviewing and approving of Pharma Quality System (PQS) Standard
-Assurance that the standards are in compliance with Swiss Law and other HA requirements
-Review and approval of documents such as Master Production Records and Batch Production Records, change control documents, transfer and validation documents, deviations and investigations
-Assurance of the readiness and support for health authority inspections
-Review and approval of local SOPs

IHRE QUALIFIKATIONEN:

-Bachelor's or Master's degree in Life Sciences
-Professional experience within the Quality field
-Experience within the Pharmaceutical Industry and with GMP
-Fluency in English

WEITERE QUALIFIKATIONEN:

Quality manager