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Quality Manager
vor 3 Wochen
**Quality Manager (f/m/d)**
100%, indefinite duration, as soon as possible
YOUR 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
- Strongly interact with Product QP's regarding Batch Release of COVID-19 Vaccine as well as Japanese Encephalitis Vaccine (Ixiaro) and future marketed products as part of the batch release team to be established at Valneva Austria
- Preparation and review of documents for batch release and QP certification (e.g., issuing, review and QA-approval of Certificates, printing, compilation, and check for completeness of executed batch records and batch release packages) in order to ensure timely release of products and intermediates
- Perform review of executed Batch Records to ensure completeness, correctness and compliance of batch related documentation
- Prepare Lot Release Protocols for batch release by Official Control Authorities (OCABR)
- Work as point of contact to internal and external partners (CMOs, other Valneva sites) in relation to batch release
- Ensure continuous improvement of the batch release process
- Tracking and reporting of key performance indicators related to batch release
- Participate in compilation of Annual Product Quality Reviews, where necessary
- Actively support Quality Assurance activities related to administration of other Quality SystemsTraining of QA GxP relevant topics
YOUR QUALIFICATIONS
- 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 in supporting Batch Release from a QA perspective
- Knowledge (or at least open minded) of electronic Quality Systems
- 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 communication skills
- Able to work cross-functional, independently but also in a team
- Proactive and solution-oriented in a fast-changing environment
- Detail oriented, quick grasp of understanding
- Excellent command of German & English (spoken and written)
- Excellent computer skills
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 € 55.000;
- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience._
