Our client is a leading organization in the pharmaceutical and biotechnology sector, operating in a highly regulated GMP environment. They are committed to delivering high-quality products that make a meaningful impact on patients’ lives. With a strong focus on innovation, compliance, and continuous improvement, the company fosters a collaborative culture where technical expertise and operational excellence are highly valued.
About the PositionWe are seeking an experiencedQC Systems Specialistto manage and optimize Quality Control (QC) systems across their full lifecycle. This role is critical in ensuring system availability, compliance, and efficiency within the QC laboratory. You will act as a key technical expert, advisor, and point of contact for QC systems, working closely with internal stakeholders, maintenance teams, and external partners to support release testing and continuous improvement initiatives.
Key Responsibilities- Manage the full lifecycle of all QC systems, including implementation, maintenance, and retirement
- Ensure timely calibration and maintenance without impacting release testing
- Maintain high instrument availability; act as main point of contact for maintenance teams to minimize downtime
- Oversee new system introductions and communicate implementation timelines clearly to team leads and management
- Act as a technical advisor and Subject Matter Expert (SME) for the QC department
- Coordinate and deliver training for new QC personnel
- Troubleshoot system issues in collaboration with the team and drive effective solutions
- Organize and prioritize daily activities to support efficient processes and timely release
- Monitor GMP systems to ensure compliance with internal procedures and safety regulations
- Identify and implement Lean improvements and efficiency enhancements
- Represent QC in cross-functional projects related to QC systems
- Lead investigations and support continuous improvement initiatives
- Author, review, and implement deviations, change controls, and CAPAs
- Create, review, and update controlled documents (SOPs, specifications, methods)
- Prepare and maintain validation documentation (VMP, URS, risk assessments, IO/PQ, data flows)
- Support data management activities, including vulnerability assessments of QC software systems
- Perform user management, audit trail reviews, and system parameter reviews in line with procedures
- Act as SME during audits and regulatory inspections
- Collaborate professionally with other departments and support broader QC goals
- Degree in Life Sciences, Chemistry, Engineering, or a related scientific discipline
- Proven experience working in a GMP-regulated QC laboratory environment
- Strong expertise in QC systems, laboratory instrumentation, and computerized systems
- Experience with system validation, data integrity, and audit readiness
- Solid understanding of deviations, change control, CAPA, and documentation management
- Demonstrated ability to lead investigations and continuous improvement initiatives
- Strong organizational skills with the ability to prioritize effectively in a fast-paced environment
- Excellent communication skills, capable of clearly conveying timelines and technical topics to stakeholders
- A proactive, solution-oriented mindset with the ability to work cross-functionally
€50000 - €70000 monthly