Quality Assurance Specialist (m/f)

the Bern region  ‐ Onsite
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Description


We are looking for a
Quality Assurance Specialist (m/f)

Reference: -en
Start: 03/16
Duration: 11 MM
Place: in the Bern region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen

Your tasks:
  • Ensure that products, systems and facilities are in state of sustainable compliance with the requirements of cGMP and regulatory authorities
  • Responsibility for all quality matters related to the activities performed in the production and during process development
  • Assure efficient and effective quality assurance activities at required cGMP level
  • Assure that the products are manufactured according to cGMP requirements
  • Review and approval of SOPs, WOIs, TEIs, FOBs, RARs and other quality related documents
  • Ensure definition of appropriate and effective CAPAs with appropriate timelines and ensure timely implementation
  • Perform QA release of batches and intermediates
  • Set batch status in LIMS and SAP, excluding QP release


Your qualifications
  • Experience in quality assurance of biological or pharmaceutical products according to cGMP requirements
  • University degree in natural sciences, medicine or pharmacy or professional scientific, medicinal or pharmaceutical training and profound working experience under cGMP
  • Know-how regarding quality assurance principles (cGMP)
  • Know-how of biological manufacturing processes
  • Profound know-how regarding Quality Assurance
  • Know-how of risk management
  • Good negotiation skills
  • German and English language skills, in both written and spoken form



Skills:
- Quality manager


Keywords: Qualitätsmanager
Start date
03/16
Duration
11 MM
From
Hays AG
Published at
23.02.2016
Contact person:
Kerstin Werner
Project ID:
1076582
Contract type
Freelance
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