Quality Assurance Manager

vor 1 Woche

Wien, Wien, Österreich Valneva Austria GmbH Vollzeit

Description:

- or only-in-class vaccine solutions.


We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world's first and only chikungunya vaccine, as well as certain third-party vaccines.


Responsibilities

  • Establish, maintain and continually improve the quality assurance management system for all aspects of the activities of Valneva Austria, compliant with coordinated policies for Quality Assurance which are consistent with current GxPs, relevant Health and Safety Regulations and other relevant current legislation
  • Lead/support projects for global harmonization of quality systems
  • Lead/support computerized system validation projects based on GAMP
  • Take over responsibilities within Valneva's electronic Quality Management System including further development of established modules and implementation of new modules on a global basis
  • Lead/support digitalization projects for paperbased systems and processes
  • Support the initiative to move electronic Quality Systems to Cloud and link with other systems to allow data sharing
  • Actively support Quality Assurance activities related to administration & Training of Quality Systems

Requirements:

  • HTL, Bachelor or Master Degree or equivalent in a relevant field (e.g., Biotechnology, Bioengineering, Chemistry, Molecular Biology, Biology)
  • At least 25 years of experience within QA / QC / GxP regulated environment, preferably in Biotechnology / Pharmaceutical Industry
  • Good knowledge of GMP guidelines and regulatory bodies
  • Experience with electronic Quality Management Systems and in Computerized System Validation
  • Skills in transferring knowledge (trainings), presentation skills for miscellaneous customers (experienced, nonexperienced audience)
  • Ability to organize and schedule work within a busy office with experience of writing and working to SOP documentation
  • Excellent computer skills, communication skills and command of German & English (spoken and written)
  • Able to work crossfunctional, independently but also in a team
  • Proactive and solutionoriented in a fastchanging environment
  • Detail oriented, quick grasp of understanding

Benefits:

  • 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, performancerelated 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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