Temporary Quality Assurance Specialist – Cell Therapy

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About the role

Bring your audit & Quality experience to Cell Therapy Join our growing Cell Therapy team in Amsterdam on a 12-month contract, in a hands-on role centred on hosting audits and Health authority inspections. You will work with batch records, Quality systems and QP’s, while helping us improve our processes as our operations grow.   Quality Assurance Specialist – Cell Therapy Amsterdam 12 month contract Hybrid, 3 days on-site   The role As a Quality Assurance Specialist, you combine hands-on Quality Assurance with audit and inspection activities and broader Quality Management System (QMS) responsibilities. In this role, you’ll play a key part in ensuring quality and compliance across our operations. Around 50% of your time will be dedicated to compiling and reviewing batch documentation, 30% on broader QMS activities, and 20% to supporting audits and self-inspections. You work closely with our Qualified Persons (QP’s) and Quality colleagues to make sure documentation is complete and correct, Quality actions are followed up and our operations remain compliant. You also help to improve Quality processes and ways of working as our site develops. What will you do? A key part of your role will be supporting day-to-day Quality operations, with a strong focus on batch documentation compilation and review. You’ll also contribute to QMS activities, training and meetings, as well as audits, inspections and the follow-up actions that arise from them. Daily operation task include: • Review batch documentation for batch disposition/QP certification. • Identify missing or incomplete documentation, coordinate actions with the right teams and follow them through to completion. • Write, review and update SOP’s, procedures, policies and Quality documents. • Review Quality and manufacturing records and identify gaps, risks, deviations and required follow-up. • Investigate Quality deviations and coordinate corrective and preventive actions (CAPA’s). • Review and approve Change Controls. • Review Quality documentation for equipment and facility as we build our Cell Therapy Import Hub. • Use available digital and AI tools to improve and update Quality documentation. • Host audits forHealth authority inspections on site, including preparation, front room and backroom support, and follow-up. • Coordinate audit and inspection activities • Compile, coordinate and draft responses to audit and inspections findings, working with the business to make sure responsesare complete and consistent. • Own the CAPA’s arising from audits and inspections, coordinate them with the responsible teams and follow them through to completion. • Conduct self-inspections on site and drive the actions that come out of this to closure. Who are you? You are experienced in audits and inspections. You know what auditors and inspectors look for and stay calm and organised when they are on site. You enjoy detailed documentation-driven work. You like reviewing documents, checking details and making sure Quality records and Batch documentation are complete, correct and compliant. You take ownership. When something needs attention, you follow it up, involve the right people and make sure it gets resolved. Including the CAPA’s that follow an audit. You will work in a small Quality team on a site that is still developing. Processes and priorities can change as we build the organisation. You are comfortable with this, stay calm under pressure and look for practical solutions. You are self-motivated, flexible and curious. You can manage several priorities at the same time and actively look for ways to improve how things are done. Essential skills and experience • A bachelor’s or master’s degree. • Experience hosting audits and Health authority inspections. • Experience coo

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