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Quality Specialist

Posted On:  25-Aug-2021
Job Category:  Operations, Quality & Engineering

At Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are driven by respect, ownership and continuous improvement. It is at the heart of everything we do. This is how we make a difference in the lives of patients, customers and associates.

 

Department Info

 

The Terumo EMEA Quality team, operating from our HQ in Belgium, provides support related to Quality Systems (QS), Quality Assurance (QA) and Quality Control (QC). Both internal and external Terumo customers within the EMEA region receive this support. Terumo Pharmaceutical Solutions (TPS) is the business unit of Terumo Europe that develops patient-oriented parenteral delivery solutions for therapeutic performance and safety.

 

Job Summary

 

As a QA Specialist in our TPS team, you ensure the quality oversight of TPS products to guarantee that all products meet the customer requirements, which are linked to both the products and the processes. In addition, you’ll contribute to the continuous improvement of the quality of the TPS products. You’ll report directly to the QA Manager TPS.

 

Job Responsibilities

As our QA Specialist, you’ll contribute to all possible QA aspects. Consequently, you’ll be required to interact with other departments and teams, in order to ensure the necessary quality of products and processes. You’ll ensure the compliance of TPS (Terumo Pharmaceutical Solutions) procedures with the relevant standards by quality.
You’ll primarily support Production in ensuring that all quality requirements are implemented and maintained. You will be the subject matter expert for deviation handling and therefore responsible for coordination and completion of non-conformities, CAPA’s etc…. You’ll interact with suppliers by performing the necessary supplier audits and you will also be responsible for the product complaint handling with focus on root cause analysis. 
In collaboration with Sales & Marketing, you’ll provide quality related information, complete customer questionnaires, review Quality agreements, lead audits and actively follow up on defined actions and countermeasures.
 By fulfilling your role, you’ll proactively provide information and training about quality requirements and GMP- rules to TPS-related departments.
 As a QA Specialist, you’ll be required to review batch records of TPS products and you’ll need to oversee the (SAP) release of TPS and OEM products. 
You’ll contribute directly to the stimulation of continuous improvement, through the set-up and active participation of improvement projects related to TPS requirements
 

Profile Description

You are enthusiastic and driven about complementing our highly qualified and international clinical team.

You have obtained a university or technical degree in engineering or an education related to either science in general, medicine or pharmaceutical sciences. An equivalent that is provided through experience, will also qualify. 

You can look back on a previous working experience, minimum 18 months, within the pharmaceutical industry and/or GMP. 

A substantial amount of knowledge related to EN ISO 13485, 21 CFR Part 820 is required. Additionally, you’ll need to be fluent in English and Dutch. This concerns both the verbal and writing skills. You also possess a strong team player mindset and strong communication skills in general, that will allow you to collaborate efficiently with associates. 
 

Offer

Working for Terumo means contributing to society through healthcare. We offer a full-time employment contract accompanied by an attractive salary package. 

We offer a fantastic opportunity to work in a top performing team. A work environment in which every associate, customer and business partner is treated with respect, where sincerity is key and where everyone always strives to find the most optimal solution. Furthermore, you’ll find yourself in an environment that promotes a mindset that embraces challenge for the future. 

Interested in joining our passionate team? Interested to find out more? Take a look at Terumo Europe's Corporate Video or at our website !
 

Contact Person

 

Bethsabee Bellinck.

Applications for this position, will be processed in the beginning of September. 

 

Terumo Europe is a core player in the EMEA healthcare market. We are a strong actor of the Terumo Corporation (Japan), producing, distributing, marketing and selling a vast range of medical devices. Terumo Europe EMEA headquarters and production facilities are located in Leuven (Belgium) with sales and marketing offices across the EMEA region.

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