Quality Assurance Manager
Vor 2 Tagen
We are a leading vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. Our team is committed to making a positive impact on global public health.
Responsibilities- Establish and maintain a quality assurance management system that meets regulatory requirements and industry standards.
- Lead projects for global harmonization of quality systems and ensure compliance with GxPs, health and safety regulations, and other relevant legislation.
- Support computerized system validation projects based on GAMP5 and take over responsibilities within our electronic quality management system.
- Develop and implement new modules on a global basis and lead digitalization projects for paper-based systems and processes.
- Support the initiative to move electronic quality systems to the cloud and link with other systems to enable data sharing.
- Actively support quality assurance activities related to administration and training of quality systems.
- HTL, Bachelor or Master Degree or equivalent in a relevant field (e.g., Biotechnology, Bioengineering, Chemistry, Molecular Biology, Biology).
- At least 2-5 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 computerized system validation.
- Skills in transferring knowledge (trainings), presentation skills for miscellaneous customers (experienced, non-experienced 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 cross-functionally, independently, but also in a team.
- Proactive and solution-oriented in a fast-changing environment.
- Detail-oriented, quick grasp of understanding.
- 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, compensation days, performance-related bonus, lunch vouchers, child care center, company events, myClubs, and full access to LinkedIn Learning.
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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