Purpose of the job:
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.
Your main accountabilities are:
- Review and approve technical documentation generated during the development process & improvement projects to ensure compliance towards applicable standards & regulations and procedures; participate to technical/design review meetings.
- Act as quality expert in project teams.
- Own and maintain the product risk management file from launch of the products.
- Write and/or approve changes & CAPA’s.
- Handle and follow-up product complaints from end users, affiliates, distributors and partners and provide timely and appropriate solutions; assess impact of complaints on public health (member of Risk Assessment Committee).
- Manage, evaluate and improve Quality Management System processes (e.g. change control, CAPA, internal audits, complaint handling).
- Master degree in bio-environment (pharmacy, biology, biotechnology) or equivalent by experience.
- 3 years experience in pharmaceutical or diagnostic environment.
- 3 years experience in a Quality department
- Customer oriented / customer friendly
- Positive, pro-active and flexible attitude
- Experience in Risk Management, Change control or CAPA is a plus
- Open minded, cooperative, takes initiative, able to communicate with impact
- Analytical, problem-solving capabilities
- Good written and oral communication skills
- Languages: Dutch & English – good knowledge written & spoken.
Up for the challenge? We welcome your cv + motivation letter by 30/09/2020 at the latest (see below).
By joining Fujirebio you contribute to a better healthcare in a company where different cultures meet each other which makes our jobs challenging and stimulating.
Our employees appreciate their rich job content and the great deal of independence within their job.
In an open, informal and dynamic work environment you will be collaborating with our scientific, commercial, operational and supportive teams.
To support this collaboration and to support personal growth of all team members we offer our employees the opportunity to develop their knowledge, skills and talents.
Our committed and engaged employees make that Fujirebio Europe (previously Innogenetics) provides innovative IVD solutions for healthcare all over the world.
Our products and services allow doctors to make fast and accurate diagnosis in different disease fields like infectious diseases, neurological disorders, oncology and genetic diseases. Based upon this specific an accurate testing, appropriate treatment can be started quickly.
We develop and manufacture diagnostic tests at our site in Ghent, as well as in Tokyo, after which they are sold worldwide by our commercial teams to hospitals and clinical labs.
Furthermore, we use our advanced experience in development and manufacturing of Diagnostic solutions and our high-quality standards for contract manufacturing projects with third parties.
Fujirebio Europe belongs to an international group (H.U. Group) with branches and colleagues in Asia, Europe and the USA. We currently employ 130 people at the headquarters in Ghent and more than 40 people in our European affiliates.