QC Transfer Expert (m/f)

REFERENZNUMMER:

277606/11

IHRE AUFGABEN:

-Main contact for QA/QC organisation and customers, e.g. Process Unit, SCM, RegCMC, PhQA, TRD
-Management of QA/QC processes and procedures
-Provide expertise and support QA/QC and other customers technical, analytical and organisational procedures in a matrix organisation
-Ensure and support deliveries, HSE, GMP and regulatory compliance for area of responsibility
-Maintain and build contacts with external experts, e.g. GQO, TRD, RegCMC, SCM, HSE etc. and ensure fast and direct communication channels
-Provide scientific and technical expertise on QA/QC procedures within the organisation
-Maintain and adhere to cGMP, SOPs
-Ensure uniform GMP standards by regular exchange with central QA function
-Generate and/or review GMP documents, e.g. testing monographs, transfer and validation documents, change requests and quality agreements
-Manage investigations regarding product quality (e.g. OOS/OOE, deviations)
-Maintain state-of-the-art knowledge of Health Authority requirements, trends, technologies, processes and systems

IHRE QUALIFIKATIONEN:

-University or academic degree in Chemistry, Biology, Pharmacy or equivalent
-German and English skills
-Experience in chemical/pharmaceutical industry is an advantage
-General IT-knowledge

WEITERE QUALIFIKATIONEN:

Quality manager