Department Info
Terumo is a manufacturer of medical devices. In Leuven, Terumo produces approximately 800 million injection needles, injection solutions, catheters and necessary accessories per year. We develop and produce products for hospitals and specifically developed products according to the needs of our pharmaceutical customers. To make this personalization possible, investments were made in a flexible machine park with a high degree of automation. We were proud to achieve the title of Factory of the Future, which testifies to progressive production technology and a people oriented organization.
Department information
Terumo EMEA Quality, operating from Leuven (Haasrode), Belgium, provides supporting services in quality systems, quality assurance and quality control to Terumo internal and external customers.
Job Summary
Development, implementation, supervision and coordination of all monitoring and process/product (re)qualification activities (IQ/OQ/PQ) related to (changes of) sterilization to assure product sterility in accordance with applicable standards.
Daily monitoring of the sterilization process of products manufactured in Terumo Europe.
Job Responsibilities
1. Develop sterilisation cycles for new product introductions and take ownership of the introduction in the plant from equipment selection to executing qualification activities in house or in collaboration with a sub contractor. Once implemented, guard compliance and efficiency of the process in close collaboration with Product Engineering.
2. Organize, perform and coordinate (re)validation activities of the sterilizers and any other critical equipment in line with company procedures and international standards.
3. Daily monitor the sterilization process and coordinate the implementation of countermeasures in case of deviating process results.
4. Monitor the need for upgrading sterilization cycles in accordance with increasing market demand and keeping cycle efficiency high at lowest cost.
5. Monitor and evaluate regulatory standards for changes to ensure compliance with applicable standards.
6. Evaluate potential sterilization impact and define required actions in case of changes.
7. Act as spokesperson for the sterilization process during customer audits & regulatory inspections.
8. Be the first point of contact for questions regarding the sterilization process for Terumo associates and the sub contractor, providing training when needed.
9. Prepare and host the Quality Review Meeting with the sub contractor and follow up on open actions.
10. Support internal audits at the sub contractor as sterilization expert.
Contact Person
Peter Coolen
Talent Acquisition Partner
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