QA Operations Specialist (m/f/d)

Terumo Europe NV; Deutschland; Vor Ort; EUR 65.000 - 90.000; Vollzeit

Benefits dieser Stelle

Competitive compensation

Career development

Cross-functional collaboration

Training and growth opportunities

Zusammenfassung

Terumo Europe is seeking a QA Operations Specialist for our CDMO plant in Leverkusen. You will ensure daily GMP operations comply with internal procedures and global regulatory expectations, providing hands-on QA presence in manufacturing and warehouse areas, performing routine quality checks, supporting quality events, and managing material status in SAP.

You will report to the Team Lead QA Operations, contribute to reliable supply of high-quality biological products to patients worldwide, and

Qualifikationen

• GMP knowledge and QA experience required in a sterile environment.
• Experience with regulatory standards (EMA, FDA, ICH, WHO).
• Proficient in SAP and data integrity practices.

Aufgaben

• Provide daily GMP oversight across Manufacturing, Warehouse, QC, and MSAT.
• Conduct routine quality monitoring of production steps, logbooks, batch records, storage and testing activities.
• Prepare batch documentation packages and perform real-time batch record review on the shop floor.
• Inspect and release cleanrooms for GMP manufacturing.
• Handle abnormal or rejected materials in SAP and maintain material master data.
• Support Change Controls, Deviations, CAPAs, and other quality events.
• Review and revise SOPs, QRAs, and MBRs to drive continuous improvement.
• Perform electronic data review to ensure data integrity and compliance.

Kenntnisse

GMP knowledge

QA oversight

Interpersonal skills

German & English communication

Proactive mindset

Ausbildung

Bachelor degree in Chemistry/Biology/related

Experience in GMP QA environment

Tools

SAP

Microsoft Office

Jobbeschreibung

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

At Terumo Europe, the Quality Assurance department plays a central role in ensuring that all manufacturing, testing, warehousing, and tech‑transfer activities meet the highest GMP and regulatory standards. Our QA Operations team partners closely with Manufacturing (OPS), Warehouse (WH), Quality Control (QC), and MSAT to safeguard product quality and patient safety.

This position is part of a dynamic, on‑the‑floor QA group that provides real‑time oversight and supports continuous improvement across the site.

Job Summary

The QA Operations Specialist ensures that daily GMP operations are executed in compliance with internal procedures and global regulatory expectations. You will provide hands‑on QA presence in manufacturing and warehouse areas, perform routine quality checks, support quality events, and manage material status in SAP.

Your work in our CDMO plant in Leverkusen directly contributes to the reliable supply of high‑quality biological products to patients worldwide. This position reports to Zhenda Whu, our Team Lead QA Operations

Job Responsibilities

• Provide daily GMP oversight across Manufacturing, Warehouse, QC, and MSAT, with a primary focus on OPS and WH.
• Conduct routine quality monitoring of production steps, logbooks, batch records, storage, and testing activities.
• Prepare batch documentation packages and perform real‑time batch record review on the shop floor.
• Inspect and release cleanrooms for GMP manufacturing.
• Perform AQL assessments following visual inspection activities.
• Oversee GMP activities for drug product manufacturing, including formulation, aseptic filling, lyophilization, visual inspection, and packaging.
• Handle abnormal or rejected materials physically and in SAP, including blocking/unblocking and maintaining material master data.
• Support Change Controls, Deviations, CAPAs, and other quality events.
• Review and revise SOPs, QRAs, and MBRs to drive continuous improvement.
• Perform electronic data review to ensure data integrity and compliance.
• Support self‑inspections, client audits, and authority inspections as SME and back‑office support.
• Take on additional responsibilities as assigned by the supervisor.

Profile Description

• Degree in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, or a related field.
• Minimum 3 years of a proven track record in GMPin QA, Exoerience in a sterile environement is a must.
• Experience with biological product development or pharmamanufacturing.
• Strong knowledge of GMP and regulatory standards (EMA, FDA, ICH, WHO).
• Able to have professional conversations in both German and English is a must.
• Strong interpersonal, communication, and organizational skills.
• Proactive mindset with the ability to influence and drive improvement.
• Willingness to work in shift‑based schedules when required. (morning, evening, night)
• Ability to pass a visual inspection qualification.
• Proficiency with Microsoft Office and common digital tools.

Offer

• A meaningful role in a mission‑driven healthcare company that is in full expansion in Germany, improving patient outcomes worldwide.
• A collaborative, high‑quality GMP environment with strong cross‑functional interaction.
• Opportunities for professional development, training, and career growth.
• A culture that values integrity, teamwork, and continuous improvement.
• Competitive compensation and benefits aligned with Terumo Europe standards.

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.