Fujirebio Europe is looking to temporary strengthen its Quality & Compliance department at the European Headquarters in Ghent with a Quality Engineer Product position (Temporary contract for 8 months).
Ensure that in-vitro diagnostic test kits are developed & maintained during the whole product life cycle to meet customer expectations & in compliance with current quality & regulatory requirements.
Ensure customer satisfaction by providing appropriate solutions to customer complaints in a timely manner as part of an outstanding post-sales service.
- You review and approve technical documentation generated during the development process & improvement projects to ensure compliance towards applicable procedures.
- You participate to design review meetings & act as quality expert in project teams.
- You own and maintain the product risk management file from launch of the products.
- You write and/or approve changes & CAPA’s.
- You handle and follow-up product complaints from end users, affiliates, distributors and partners and provide timely and appropriate solutions.
- You discuss complaints which could have consequences on public health and liaise with the Risk Assessment Committee in case of potential Reportable Events.
- You provide support to the QC department (troubleshooting, training, expertise, …).
- You optimise, validate and implement QC methods and procedures (QC, FQC, Stability, Sampling) in order to guarantee product quality until end of shelf life.
- Master degree in bio-environment (pharmacy, biology, biotechnology) or equivalent by experience
- 3 years quality experience in pharmaceutical or diagnostic environment
- Insight in customer & market requirements
- Positive, pro-active and flexible attitude
- Experience in CAPA is a plus
- Team player: open minded, cooperative, takes initiative
- Good problem solving – problem analysis
- Project management experience
- Good written and oral communication skills
- Languages: Dutch & English – good knowledge written & spoken
We welcome your application and the possibility to evaluate your curriculum!
Talent & Reward Manager
Tel: 09/ 329 16 26