QUALITY ASSURANCE AND REGULATORY AFFAIRS ASSOCIATE (m/f)

West Switzerland  ‐ Onsite
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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
Start date
ASAP
Duration
6 MM++
(extension possible)
From
Hays AG
Published at
27.07.2015
Contact person:
Kerstin Werner
Project ID:
953296
Contract type
Freelance
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