QA Operations Specialist

About the Role

We are seeking two QA Operations Specialists for temporary 6-month assignments to cover maternity leave at a leading global healthcare organization focused on radioligand therapies and GMP production. These roles support the operational QA activities on-site, with a strong emphasis on timely and compliant batch release, documentation oversight, deviation management, and real-time decision-making in a highly regulated environment. Key Responsibilities

QA review and support for the batch release process On-site QA oversight during production operations Complete document lifecycle management & batch archiving Release of incoming materials Visual Monitoring during unannounced inspections Review and approval of SOPs, work instructions & protocols Support deviation investigations and timely closure Review of OOS, OOT, OOE, and system suitability investigations Support CAPA & change control execution Assist during audits, inspections, and improvement initiatives Who We\'re Looking For

MBO/HBO-level (preferably scientific) GMP knowledge and experience in QA or regulated environments Strong documentation discipline & attention to detail Risk-based decision-making under time pressure Strong communicator and team collaborator Preferred

Experience with radiopharmaceuticals, radiation, or PET production Shift Times (8-hour shifts, each incl. 1 × 30 min break):

Early Shift:

06:30-15:00 Late Shift:

14:30-23:00 Night Shift:

22:30-07:00 Daytime: 0% Morning: +20% Evening: +30% Night: +40% Let op: vacaturefraude Important: job fraud Unfortunately, job fraud is becoming more common. Beware of such scams: * We will never ask for personal information (such as a copy of your ID, bank details, or social security number) via WhatsApp or during a video call. * If you\'re unsure whether a vacancy or contact person is legitimate, please reach out to us directly using the official contact details on our website.

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