Terumo Europe NV

Quality Specialist

null, Flanders, BE

Company: Terumo Europe NV

Category: Computer and Mathematical Occupations

Published on 2022-01-14T11:19:57.000000Z


Taken en verantwoordelijkheden 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 procedures with the relevant standards by quality and you’ll update procedures when needed.

 

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. You’ll assist Production in ensuring that all quality requirements are implemented and you’ll provide additional support in case of deviations or projects. You’ll interact with suppliers by performing the necessary supplier audits. 

 

By fulfilling your role, you’ll proactively provide information and training about quality requirements and GMP- rules to TPS-related departments. In addition, you’ll ensure the yearly GMP-training for all TPS employees. 

 

You’ll be responsible for the product complaint handling with focus on root cause solving, as well as non-conformity handling and CAPA handling. 

 

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.

 

 

Profiel kandidaatProfile 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 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. 

 

 

 

Geboden wordt 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. 

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