QPIP (Quality Person in Plant)

Job description

As a Quality Person in Plant (QPIP) , you provide quality oversight over the production of personalized cell therapies, supporting both clinical and commercial operations in a sterile GMP environment. This role combines scientific understanding with strong interpersonal skills and a keen eye for detail. What can you expect? As a QPIP, you will work daily in our sterile GMP environment, supporting the production of personalized cell therapies. You combine process knowledge with a strong quality mindset to ensure that every step meets our high standards. Quality oversight in the cleanroom (on-the-floor witnessing) : You support operators during cell therapy manufacturing by being physically present on the shop floor (“on-the-floor witnessing”). You act as the first point of contact for operators on quality, process discipline, and documentation. You guide them in resolving production issues and ensure that any concerns are escalated in a timely and appropriate manner by involving the right stakeholders. You monitor compliance with procedures in real time and ensure that all interventions are carried out correctly and in line with GMP requirements. Compliance & Quality Assurance : You perform periodic quality checks and audits related to processes, documentation, and manufacturing activities. You proactively promote compliance to reduce non-conformities and deviations within the supported areas. Batch Review & Escalation : You review production procedures and batch records and take the lead in the operational batch release process. You identify deviations, assess their impact, and escalate where necessary in line with quality guidelines, always prioritizing patient safety and compliance. Deviations & Documentation : You support the logging, investigation, and assessment of deviations, CAPAs, change controls, and complaints. You review process documentation to support unit operations and release activities. <span data-ccp-props="{"134233117":false,"134233118&am