Quality Systems Expert Validation

Datum:  25-jun-2022
Categorie:  Operations, Quality & Engineering

Bij Terumo verbeteren we levensreddende medische technologieën voor onze samenleving. 
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Het is de kern van alles wat we doen. Zo maken we een verschil in het leven van patiënten, klanten en medewerkers.

Department Info

 

Terumo EMEA Quality operating from Haasrode, Belgium, provides supporting services in quality systems, quality assurance and quality control to Terumo internal and external customers on an EMEA basis.

Job Summary

 

As part of this department, the QS Validation Expert ensures the quality oversight of the process validation activities. Main responsibility is to ensure EO sterilization validation and process validation activities comply with the applicable European and FDA regulations, guidelines and Terumo Global Quality Policies. 

Job Responsibilities

 

Most of the time, you’ll be involved in maintaining the Process validation and EO Sterilization validation process in Terumo Europe, more concrete: 

  • You’ll maintain the QMS procedures on process validation of EO sterilization and manufacturing processes, including risk management process (process FMEA) to be compliant with applicable European and FDA regulations, guidelines and Terumo Global Quality Policies.   
  • You’ll supervise the EO sterilization validation engineer and train the process validation engineers.
  • You’re responsible for maintaining and doing the follow-up of the VMP’s and periodic reviews to ensure that processes are timely re-validated.
  • You’ll review and approve EO sterilization validation files for compliance with  EN ISO 11135
  • You’ll coach QA engineers in the review process of process validation files and monitor this review process.
  • Follow-up EO Sterilisation validation subcontractor
  • Responsible for non-conformity handling related to process and sterilisation validation issues (including audit non conformities): investigate CAPA need, guide investigation to the root cause of the non-conformity and review corrective actions proposed. Ensure proper documentation and follow-up implementation of corrective actions, effectiveness evaluations for CAPA and closure of the non-conformity. 

 

A smaller part of your time, you’ll execute and support quality systems audits

  • You’ll participate in the internal audits of Terumo Europe
  • You’ll support regulatory, corporate and customer audits as subject matter expert for process and sterilization validation, supported by the validation engineers.

Profile Description

 

  • University or technical degree in engineering, scientific, medical or pharmaceutical oriented education, or equivalent by experience
  • Experience in the technical domain of EO sterilisation validation and process validation. 
  • Profound knowledge of EN ISO 11135, EN ISO 13485, 21 CFR Part 820, GHTF/SG3/N99-10
  • Minimum 5 years professional experience in medical and/or pharmaceutical environment
  • Good working knowledge of English (written and spoken). Knowledge of French is an asset. 
  • Team player with strong communication skills to collaborate with different partners across our organization 
  • Being able to work accurately according to guidelines 
  • Open to work full time 
     

Offer

 

Working for Terumo means contributing to society through healthcare.  

Terumo offers an attractive salary and benefits package. Besides meal vouchers, interesting insurances, 100% public transport reimbursement, you also have the possibility to lease an (e-)bike.  

We offer an opportunity to work in a top performing team. An organisation where everyone is treated with respect. We strive to create a diverse, equal and inclusive work environment. We invest in our associates by offering a broad array of development opportunities.  

Linked with our core value Care, Terumo allows a hybrid way of working, combining office with home-based work. For this role, you’re allowed to work very flexible switching between home or office based. To ensure team connection, presence in the office is asked on Monday (morning) for weekly team meeting. 

During your recruitment process, you’ll be able to have conversations with Bert Pipeleers as the hiring manager and other passionate Terumo associates.  

Interested to contribute to the growth of Terumo? Interested to find out more? Have a look at Terumo Europe's Corporate Video or visit our website!

Contact Person

 

Bethsabee Bellinck. 

Terumo Europe is een belangrijke speler in de EMEA healthcare markt. We maken deel uit van Terumo Corporation (Japan) en produceren, verdelen & verkopen medisch materiaal. Het EMEA hoofdkwartier en productiefaciliteiten van Terumo Europe zijn gevestigd in Leuven (België). Onze saleskantoren zijn verspreid over de EMEA regio.

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