Talentmark

QA Operations Specialist

Posted: 8 hours ago

Job Description

Step into a role where your expertise in Quality Assurance directly contributes to the timely release of life-saving medicines. As a QA Operations Specialist, you will be at the core of GMP operations, ensuring every batch meets the highest standards of compliance and quality. If you thrive in a fast-paced, solutions-focused environment and want to make a meaningful impact, this is your opportunity.Key Responsibilities:Review batch release documentation and support the Quality Responsible during the release processProvide on-site QA support for operational activities and interventionsEnsure proper lifecycle management and archiving of batch documentationRelease starting materials and incoming goods in line with applicable quality standardsPerform visual monitoring during unannounced inspectionsReview and approve operational procedures, protocols, and work instructionsManage deviations, including timely impact assessments and closureReview and approve investigations of OOS, OOT, OOE, and system suitability failuresSupport timely execution of CAPAs and defined corrective actionsAssist in internal audits, inspections, and continuous improvement projectsEssential Requirements:MBO/HBO-level education, preferably in a scientific disciplineFluent in English, both written and spokenFamiliarity with quality systems (GMP)Basic understanding of regulatory requirementsStrong affinity with and awareness of quality-related topicsExcellent organizational skills and attention to detailDemonstrates appropriate urgency and ownership of assigned tasksWillingness to work in shiftsDesirable Requirements:Experience with radiation, PET or radiopharmaceuticalsWhat we offer:Yearly salary: €52,000 – €64,000Shift allowance: between 20% and 40%Direct contract with our client

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