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About the job
Sterima is part of the Family owned Pollet Group Company. Since 1972, Sterima is providing services for the Belgian healthcare and grew into a valued partner for the Belgian hospitals and Healthcare. Entrepreneurial enthusiasm, professionalism, a passion for the service to our Customers, a quality mindset in what we do every day, are the key ingredients that define Sterima’s DNA. Sterima continues to evolve, is investing heavily in additional capabilities and preparing itself for future growth. To support this future growth, Sterima is looking for a pharmacist based in Kortrijk.
YOUR ROLE
- Taking responsibility for the quality and compliance for all activities based in the site in Kortrijk. This encompasses the sterilisation services, the production of nursing and the production of dialysis concentrate for our European customers. You will work closely with all functions on site to continuously improve and support our quality standards and quality awareness.
- Follow-up, review, adjust and continuous improve of the Quality processes and the Quality Management System (QMS) in line with the ISO 13485:2016 standard.
- Support of the quality, compliance and continuous improvement culture.
- Owner of the following key QA processes: complaint handling, management of internally identified quality incidents, CAPA follow-up, internal audits, product release processes.
- Responsible to ensure the annual qualification & calibrations of all critical equipment for the site in Kortrijk.
- Monitoring of the internal audit program for the site, qualification of internal auditors, conducting quality walkthroughs and internal audits.
- Active role in hosting external audits & inspections and follow-up on the actions.
- Documentation and implementation of CAPA’s, including effectiveness checks for these CAPA’s. Reviewing, and implementing effective procedures and work instructions within the QMS. Coaching & training key personnel across all teams.
- Review and approve QMS documents, computer system validation, lab results, complaints, deviations, CAPA’s, quality agreements, timesheets, purchase orders, invoices, protocols and reports.
Profile
SKILLS & EXPERIENCE
- Team player, enjoying working in a hands on & professional company, who easily connects well with colleagues and external QA teams within our customer base.
- Pharmacist by education holding a specialisation as industrial or hospital pharmacist.
- Relevant experience in a QA team of a medical devices company is a nice asset but not necessarily required.
- Knowledge of the ISO 13485 norms and healthcare recommendations for sterilisations, the evolving Medical Device Regulation, or certainly a strong interest to get to learn them.
- Fluent communication in Dutch and English, written as well as oral. Additional knowledge of French is an asset.
Our Offer
WHAT WE OFFER
- A responsible and impactful position within a stable and growing family business active in healthcare.
- A key role at the site in Bissegem (Kortrijk) with room for autonomy and initiative.
- Collaboration with a professional and committed team where quality and continuous improvement are central.
- An attractive remuneration package, tailored to your experience and responsibilities, supplemented with fringe benefits.
- A people-oriented working environment with a focus on a healthy work-life balance.
About the company
Sterima, part of Pollet Group, provides sterilisation services for hospitals & medical device companies in the BENELUX. With a clear focus on quality & logistics, Sterima distinguishes itself as a service provider in this challenging market. Pollet Group, headquartered in Waregem, has operations in 17 countries and is active in 3 segements: the water treatment sector, the swimming pool industry and the medical industry. Together the group contains 2000 employees.
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