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