About the position
In taking up this position you develop and implement quality systems in compliance with the applicable legislation and standards to ensure continuous Quality Management System (QMS) certifications which is key for the sales of our in vitro diagnostics products.
Your key tasks will be to:
- screen the regulatory environment to identify new QMS standards, regulations and guidelines;
- perform and support different departments in the GAP analysis of QMS legislation;
- translate QMS requirements into compliance and cost-efficient QMS documentation;
- plan, prepare, coordinate and act as spokesperson during external audits;
- prepare Management Review Meetings and propose improvements and solutions;
- discuss and follow up actions plans regarding external audits and Management Review Meetings with involved stakeholders;
- supervise the CAPA process within the organization;
- establish the annual GxP training program;
- develop, update and give Gxp related trainings;
- supervise the qualification process and ensure the compliant status of the training database;
- stay up to date with the industry practice on QMS standards implementation by reading specialized literature, networking across the industry and interaction with regulatory authorities.
- Master degree in bio-science (pharmacy, biology, biotechnology) or equivalent by experience.
- 5 years experience in a high quality environment (ISO, FDA).
- Very good knowledge of applicable GxP regulations
- Excellent Communication skills: power of persuasion / impact
- Strong planning & organisation skills
- Good problem solving / problem analysis skills
- Project Management
- Creative and innovative
- Open minded, cooperative & taking initiative
- Languages: Dutch & English – good knowledge written & spoken.
Up for the challenge? We welcome your cv + motivation letter before 05/03/2021 at firstname.lastname@example.org.
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.