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Operational Technician/Engineer
Terumo Europe —België
A supportive and collaborative team culture with open communication and shared knowledge, combined with coaching and development opportunities.

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Quality Systems Specialist (m/f/d)

Terumo Europe
België

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Vacaturegegevens

9 dagen geleden

Kwalificaties

Productie
Communicatieve vaardigheden
Duits

Volledige vacaturetekst

At Terumo, we advance lifesaving medical technologies to benefit society. Are you eager to make a difference with us? Here, you’ll grow your expertise while staying true to your personal aspirations.

Guided by our Japanese heritage, we act with respect, take ownership, and pursue continuous improvement. If you see yourself in our values, keep reading; this might be the opportunity you're looking for

Department Info

Terumo Pharmaceutical Services (TPSG) in Leverkusen is part of Terumo’s global Pharmaceutical Solutions division, supporting pharmaceutical and biotechnology companies with high-quality contract development and manufacturing services.

Within TPSG, the Quality department plays a critical role in ensuring compliance with GMP requirements, maintaining robust quality systems, and safeguarding product quality for our partners and patients. The team collaborates closely with internal departments, suppliers, and external stakeholders to drive continuous improvement and operational excellence.

Job Summary

As Quality Systems Specialist, you are responsible for coordinating and executing key quality system activities to ensure compliance with internal policies and applicable regulatory requirements.

You will play a central role in supplier qualification, audit readiness, KPI monitoring, and the management of quality processes such as deviations, CAPAs, and change controls. Through your work, you contribute directly to maintaining high-quality standards and supporting TPSG’s compliance framework.

Job Responsibilities

Your main responsibilities include:

Execute supplier qualification and requalification activities for service providers, GMP materials, and computerized systems (e.g. audits, questionnaires, certificate management)
Manage and execute quality processes, including:
- Change control
- Deviation management
- CAPA management
Collect, analyse, and report Key Performance Indicators (KPIs) to support quality monitoring and continuous improvement
Support and participate in internal audits, client audits, and regulatory inspections
Collect and prepare data for Management Review and Annual Product Review (APR)
Develop, maintain, and continuously improve Standard Operating Procedures (SOPs) related to the Quality Management System
Support additional quality activities such as training coordination and documentation management

Profile Description

Education & Experience

Degree in Biology, Pharmacy, or a related scientific discipline
Minimum of 5 years’ GMP experience within the biotechnology or pharmaceutical industry
Experience in one or more of the following areas:

CDMO environments
Aseptic filling
Biologics manufacturing or testing

Proven experience in implementation and maintenance of Quality Management Systems
Familiarity with electronic quality systems such as Veeva, MasterControl, TrackWise, or SAP
Proficiency in German (business and technical level) is considered an advantage

Skills & Competencies

Strong communication skills with suppliers and internal stakeholders
Excellent written and verbal communication in English
Structured, task-oriented team player with strong stakeholder management capabilities
Strong interpersonal skills to collaborate effectively across departments and external partners

Offer

At Terumo, we are committed to Advancing Healthcare with Heart. We offer:

A meaningful role in an international healthcare company with a strong purpose
A collaborative and quality-driven work environment
Opportunities for professional development and continuous learning
A culture of respect, teamwork, and continuous improvement
Competitive compensation and benefits package

Contact Person

Jan Swinnen, Talent Acquisition Lead

Working at Terumo means advancing healthcare with heart. Here, you are empowered to grow your own way, inspired to create to innovate, and supported as we get there together. Join us in shaping a healthier future for our patients, society, and each other.

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implementation division vacatures

Quality Systems Specialist (m/f/d)

Operational Technician/Engineer

RAMS & ILS engineer – Defense

Senior Associate Company Secretary

Mainframe DB2 System Engineer

Mainframe System Engineer

Senior Expert Software Engineer

Enterprise Architect for Core Business Capabilities

System On Chip Embedded Software Engineer

Senior Kafka Engineer / Solution Designer

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