Description
We are looking for a
Quality Specialist in Pharmaceuticals (m/f)
Reference: -en
Start: 10/16
Duration: 12 MM++
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- 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.
Your qualifications
- 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.
Skills:
- Quality manager