QC Manager (f/m/d)


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Kontakt: Stephanie Stübler, BSc (WU)
Telefon: +43-1-20620-1348

Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

 

Your responsibilities

 

  • Management of QC Analytics. Lead lab team (approx. 6 team members)
  • Implement and validate assays required for GMP release and stability testing according to relevant guidelines (e.g. ICH, FDA; EP, AMBO)
  • Supervise qualification/maintenance of equipment required for GMP release and stability testing according to relevant guidelines (e.g. ICH, FDA; EP; AMBO)
  • Planning and/or supervision of GMP testing including trouble shooting and data analysis.
  • Ensure efficient daily operations by coordinating resource allocations cross functions as needed.
  • Continues process improvements
  • Perform data review/approval/release required for release of raw materials, intermediate and final products
  • Maintain and ensure high quality of method performance
  • Create/review/approve Development Reports, Validation Protocols/Reports, SOPs & related documents
  • Issue, manage and close-out deviations, changes, investigations and CAPAs in a timely and independent manner

 

Your qualifications

 

Minimum requirements:

  • Completed master or PhD degree in Natural science studies (Biology, Chemistry, Biotechnology, etc.)
  • A minimum of four years GxP experience in the field of pharmaceutical production or quality control
  • Excellent analytical/problem solving skills
  • Excellent leadership, communication, organizational, documentation management and teamwork skills required
  • Good working knowledge of ICH/FDA/EMA/GMP and other applicable regulatory guidelines
  • Confident handling in MS Office
  • Very good German and good English skills
  • Accountability, decision making, ability to work in a team

Desirable requirements:

 

  • Computerized system validation

 

Our offer

 

  • Open, appreciative company culture with innovative spirit and attractive assignments
  • International surrounding with flat hierarchies
  • Good team spirit in a strong and highly motivated team
  • Wide range of benefits like flexitime, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events

 

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 50.000 gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

 

 

 

 



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