QC Systems Specialist, Hoofddorp, Noord-Holland

About the Company
A global pharmaceutical organization operating within a highly regulated GMP environment, focused on ensuring product quality, patient safety, and compliance across its laboratory and manufacturing operations. The company relies on advanced analytical systems and robust quality control processes to support the release of high-quality pharmaceutical products worldwide.

Role Description
As a QC Systems Specialist, you will be responsible for managing the full lifecycle of Quality Control systems, ensuring laboratory equipment, software systems, and associated processes are maintained in a state of compliance, availability, and reliability. You will act as a key technical expert within the QC department, coordinating maintenance, calibrations, system implementations, and continuous improvement initiatives. In this role, you will collaborate closely with maintenance teams, quality assurance, and laboratory staff to ensure minimal downtime, full GMP compliance, and efficient laboratory operations.

Key Responsibilities

• Manage the full lifecycle of QC systems, including laboratory equipment and software systems.
• Ensure timely calibration and maintenance of instruments without impacting testing and release timelines.
• Act as primary point of contact for maintenance teams to minimize equipment downtime and ensure system availability.
• Oversee introduction and implementation of new laboratory systems and equipment, including timeline coordination.
• Act as technical advisor and SME within the QC department for system-related topics.
• Coordinate training for new personnel and ensure effective system onboarding.
• Troubleshoot system and equipment issues and coordinate cross-functional resolution efforts.
• Ensure compliance with GMP regulations, internal policies, and safety requirements for QC systems.
• Monitor system performance and support continuous improvement and Lean initiatives.
• Lead and support deviations, CAPAs, change controls, and investigations.
• Review, write, and implement controlled documentation (SOPs, specifications, methods).
• Support validation activities including URS, VMP, risk assessments, and IOQP documentation.
• Conduct system vulnerability assessments and support data integrity improvements.
• Perform audit trail reviews and ensure system compliance with procedures.
• Act as subject matter expert during audits and regulatory inspections.
• Collaborate with cross-functional teams to support QC and wider organizational objectives.

• Bachelor’s or Master’s degree in Life Sciences, Chemistry, Pharmacy, or related field.
• 5+ years of experience in Quality Control, QC systems, or laboratory environments within a GMP-regulated industry.
• Strong knowledge of QC laboratory systems, analytical equipment, and computerized systems.
• Experience with GMP documentation, deviations, CAPA, and change control processes.
• Experience with validation documentation (URS, VMP, risk assessments, IOQP).
• Strong troubleshooting and problem-solving skills in a technical laboratory environment.
• Experience with audit support and regulatory inspections.
• Strong organizational and prioritization skills.
• Ability to work cross-functionally in a matrix environment.
• Strong communication skills in English.

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