Quality Specialist in Pharmaceuticals (m/f)

REFERENZNUMMER:

317870/11

IHRE AUFGABEN:

-You will implement the controlled document strategy for product development quality and the supported business partners for all relevant regulatory compliance standards and processes related to clinical development and safety/pharmacovigilance.
-You will develop standards, policies and SOPs, from identification of needs, to execution of development and deployment of outputs and materials.

IHRE QUALIFIKATIONEN:

-Solid knowledge of GCP, PV and regulatory requirements.
-Solid experience in the pharmaceutical industry, preferably development and working in a GxP regulated area; understanding of global expectations of health authorities in the area of pharma development.
-Experience in preparation, development and administration of GxP standards and processes.
-Organizational awareness (e.g. interrelationship of departments, business priorities), including significant experience in working cross-functionally and in global teams.
-Demonstrated knowledge of GCP, pharmacovigilance/drug safety and regulatory requirements, as well as analytical, organizational and planning skills.

WEITERE QUALIFIKATIONEN:

Quality manager