QA Manager Production

Terumo is a manufacturer of medical devices. In Leuven, Terumo produces approximately 800 million injection needles, injection solutions, catheters and necessary accessories per year. On the one hand we develop and produce products for hospitals, on the other hand we produce specifically developed products according to the needs, questions and medicines of our pharmaceutical customers. To make this far-reaching personalization possible, investments were made in a flexible machine park with a high degree of automation. We were very proud to recently achieve the title of Factory of the Future, which testifies to progressive production technology and a people-oriented organization.

Management of the Production Quality Management system in line with QS procedures. Management of the QA Production section to provide proper control and support to manufacturing and supportive activities. Final responsible for release of goods.

1) Quality Strategy
? Develop and implement the strategy related to the quality assurance of the materials, components and products. Ensure that proper control systems are applied on materials, components and products to guarantee at all times a safe and defect-free product to the patient.
? Control and follow-up of internal GMP to secure the compliance to the internal requirements and the external regulations in all stages of the process.

2) Interactions:
? Sales and Marketing:
? Provide quality related information to customers via the sales and marketing department and via customer audits.
? Production:
? Ensure customer and quality requirements are implemented and respected in all stages of the production process
? Provide quality related support to production in case of deviations or projects
? Suppliers
? Performing supplier audits to ensure that selected suppliers can guarantee the required quality level

3) Training:
? Coaching and development of the co-workers to ensure that competences, skills and know-how are optimal used and to ensure the good departmental working
? Pro-actively provide information and training about the current quality requirements and GMP-rules to production-related departments.
? Ensure yearly GMP-training for all production employees.

4) Deviation management:
Supervising the handling of product and process failures (internal and external) and the evaluation of the countermeasures developed on preventing reoccurrence.
? Handling of product complaints of Terumo Europe Production customers with focus on root cause solving
? Non-conformity handling
? CAPA handling:
? Trend analysis:

5) Batch Release:
? Ensuring that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured before a device is released as delegated by the PRRC.
? Ensuring in time release to the market of all finished products produced at Terumo Europe
? Review of batch records
? (SAP) release
? Authorised for release under concession
? Handling of the products recall from the market, in conjunction with the CEO, Quality Systems Manager, Director Quality Operations and VP Quality, Regulatory and Vigilance.

6) Document management:
? Ensure compliance of Production procedures with the relevant standards by quality review and approval of the procedures.

7) Improvement:
? Active stimulation of continuous improvement through daily interactions and set-up of improvements projects. Information and training of the organization about the quality requirements and GMP.
? Review and approval of change control files (CoC, Mod Sheet, validation records,…) in line with the applicable procedures and standards.