Website Valneva
Valneva
Company : Valneva
We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.
We have leveraged our expertise and capabilities both to commercialize three vaccines, including the world’s first and only chikungunya vaccine, and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease and Zika.
With operations in Austria, Canada, France, Sweden, the United Kingdom, and the U.S., we are committed to making a positive impact on global public health.
Together, we are a global Company which is open to people of all backgrounds. Our diverse and inclusive workforce makes Valneva a great place to work.
Responsibilities
Work as primary Quality Assurance point of contact to internal and external partners (Third Party Logistics Providers), other Valneva sites)
Lead/support projects in the life-cycle of Valneva’s products at external partners from a QA perspective
Perform review, QA approval and administration of external documents (e.g. Reports, Deviations, Changes)
Take over responsibilities for certain Valneva’s Quality Systems
Responsible for the maintenance and continuous improvement of QM-Systems related to the oversight of external partners/Third Party Logistics Partners (e.g. handling of external non-conformance records, documents and Change Controls)
Interact with QP’s as well as other internal stakeholders regarding Quality Oversight of Third-Party Logistics Partners operations for marketed products
Tracking and reporting of key performance indicators
Participate in compilation of Product Quality Reviews
Contribute to the continuous improvement of the quality assurance management system for all aspects of the activities of Valneva USA Inc., compliant with coordinated policies for Quality Assurance which are consistent with current GMDPs, relevant Health and Safety Regulations and other relevant current legislation
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 3-5 years of experience within QA/ GMP regulated environment, preferably at a manufacturing site in Biotechnology / Pharmaceutical Industry
Good knowledge of GMP regulatory framework and regulatory bodies
Experience with cold chain distribution
Experience working with third Party Logistics Providers
Excellent communication skills and able to work cross-functional, independently but also in a team
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
Proactive and solution-oriented in a fast-changing 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