Senior Associate QA

Location: Breda, Noord-Brabant  |  Sector: Pharmaceuticals  |  Start Date: 9/6/2023  |  Job ref: 51449

Associate Quality Engineer

The Company
Our clients is one of the leads from the Biotechnology industry who try to improve patients’ lives, by distributing their medicines to hospital and pharmacies in 100 different countries in the world, to over 10 million patients, in Europe, Turkey, Middle East and Africa Regions.

 Role Description
As a Qualification & Validation Engineer, you will be responsible for perform QA oversight for validation of equipment, automation and information systems and for Quality Risk Management, as well perform review and approval of equipment and automation validation documentation, ensuring that Corporate, Site and Regulatory requirements are met.

– Process, equipment and IS validation, agrees on strategy and provides guidance regarding design, characterization and validation in cooperation with PD / M&E / IS, while ensuring GMP quality and compliance.
– Reviews and approves validation documentation, reviews and approves changes to equipment.
– Reviews and approves changes to M&E procedures (change over process, preventive and corrective maintenance), device and combination product.
– Quality Risk Management (QRM), represents QA in QRM activities (pFMEA, QRAES, Computer system compliance), and change control.
– MBO or Bachelor’s degree in Life Sciences or process technology related field or the equivalent combination of education and/or experience.
– Relevant experience in the pharmaceutical or medical device industry with experience in Equipment and Automation Validation.
– Good Manufacturing Practice (GMP), equipment and automation/IS validation, knowledge with the ability to interpret and apply in mainly routine cases.
– Manufacturing and/or Quality analytical processes and operations.

Other information
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About us

Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.

SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.

Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.

Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.