Darum lohnt es sich
It also provides operational support for new technology implementations, continuous improvement initiatives, and product‑portfolio projects to enable compliant, scalable clinical manufacturing operations.Main responsibilities include the following:Lead investigations into non‑conformities, drive corrective and preventive actions (CAPAs), and verify closure in collaboration with Quality.Provide operational and technical input and hands‑on assistance for commissioning, qualification, and GMP‑compliant operations.Support technical assessments and pilot testing, contribute to process validation and SOP/work‑instruction development, and help ensure readiness for transfer to operations.Collaborate with Quality, Engineering, Project Management and other local functions to resolve start‑up and ramp‑up issues and mitigate operational risks.Support generation and improvement of required GMP documentationSupport the technical implementation of New Product Introductions (NPI) in F2P2.Responsibility for successful aseptic process simulation (APS) with hand-over to operational teamFor this position we are looking for an experienced professional with working experience in a highly regulated environment (F Senior Operations Process Specialist (m/f)The Senior Operations Specialist supports the CM&T Operations organization and the Facility Start‑Up Manager.
The role is responsible for executing non‑conformity (NC) and NC/CAPA processes and for supporting F2P2 Next Level start‑up activities.
