Description
We are looking for a
QUALITY ASSURANCE AND REGULATORY AFFAIRS ASSOCIATE (m/f)
Reference: -en
Start: asap
Duration: 6 MM++
Place: in West Switzerland
Branch: Herstellung von pharmazeutischen Erzeugnissen
Your tasks:
- Activities concerning SOP system, Quality Manual and related
- Activities concerning deviation and change control system
- Corrective and Preventive Actions (CAPA)
- GMP/product quality decisions in conjunction with regional quality teams
- Warehouse and distribution activities
- Plan, coordinate, control and take care of all activities needed to obtain and maintain registration
- Evaluate and submit registration files in order to obtain the market authorization (MA) in the best time frame
- Submit variation files to enhance the Life Cycle Management (LCM)
- Periodic Update Safety Reports (PSUR) submission and follow-up on Monitored Release (MR)
- Coordinate Dear Doctor or Pharmacist Letter (DDPL) and Dear Investigator Letter (DIL)
Your qualifications
- Master Degree in Pharmacy, Chemistry or Biochemistry
- Strong knowledge of GMP/GDP
- Experience within quality, compliance, regulatory or laboratory units
- English, German and French skills
Skills:
- Quality manager
Keywords: Qualitätsmanager