QA Ops Qualification & Validation Specialist (m/f/d)

Department Info

You will join the Quality Assurance (QA) team within our CDMO plant in Leverkusen. The QA Operations team plays a key role in ensuring that all manufacturing, testing, engineering and warehouse activities comply with GMP standards and internal quality requirements.

Working closely with Manufacturing, Engineering, QC and Supply Chain, the team provides on-the-floor QA oversight, supporting operations to ensure safe, compliant and efficient production of biological products.

Job Summary

As a QA Operations Specialist, you ensure that daily operations across manufacturing, quality control, engineering and warehousing are fully compliant with GMP and internal procedures.

You will act as a key QA partner on the shop floor, providing guidance, performing document reviews, and supporting quality events such as deviations, CAPAs and change controls. In addition, you will play an important role in qualification and validation activities, ensuring these are executed in line with regulatory expectations.  This position reports to the QA  Ops Team Leader, Zhenda Wu. 

Job Responsibilities

• Provide QA oversight of GMP operations across Manufacturing, Engineering, QC, Warehouse and MSAT activities
• Perform routine quality monitoring including review of batch records, logbooks and operational activities
• Support real-time batch review and preparation of batch documentation packages
• Ensure QA compliance during qualification and validation activities
• Perform cleanroom release activities for GMP manufacturing
• Oversee quality aspects of drug product manufacturing (formulation, aseptic filling, lyophilisation, inspection and packaging)
• Manage abnormal and rejected materials, including SAP handling (blocking/unblocking, master data updates)
• Support deviations, CAPAs, change controls and other quality events
• Contribute to the review and improvement of SOPs, risk assessments and batch documentation
• Perform electronic data review ensuring data integrity and GMP compliance
• Support internal, client and regulatory inspections
• Actively contribute to a strong quality culture on the shop floor

Profile Description

• Bachelor’s, Master’s or PhD in Life Sciences (e.g. Chemistry, Biochemistry, Microbiology, Biology or related field)
• Minimum 3 years of experience in a GMP-regulated environment (QA, QC, Manufacturing or Technical Operations)
• Experience with biological or biopharmaceutical products is an advantage
• Strong knowledge of GMP and regulatory standards (EMA, FDA, ICH, WHO)
• Proactive mindset with the ability to influence and drive improvements
• Strong communication, organisational and stakeholder management skills
• Comfortable working in an operational shop floor environment
• Experience with SAP and Microsoft Office tools
• Fluent in German and English
• Willingness to work in shifts when required

Offer

At Terumo Europe, you will join a company committed to contributing to society through healthcare.

• A dynamic and international GMP-regulated CDMO environment
• The opportunity to work close to operations and have direct impact on product quality and patient safety
• A collaborative culture focused on continuous improvement and learning
• Opportunities to develop within Quality, Manufacturing and global operations
• A workplace where innovation, quality and integrity are at the core of everything we do

Contact Person

Jan Swinnen - Talent Acquisition Lead
Note: Please submit applications in English through the link provided in this job advertisement.