Greater Bern Area
· GMP Delegate for the engineering department o Support in the preparation of CAPAs and deviations o Carrying out deviation investigations including root cause analysis (deviation investigations) o Support of technical specialists (SMEs) in the preparation and review of technical instructions · Generating and approving all necessary Commissioning & Qualification (C&Q) documents · Ensure corrective actions meet acceptable reliability standards and are completed on time · Review and approval of C&Q related design documents · Responsible for the development and continuous improvement in relation to compliance issues, setting working standards with current GMP and regulatory requirements in collaboration with the quality department · Participation in GMP regulatory inspections by authorities and customers in general and for all CVQ related topics · Creation, review and approval of new and updated qualification procedures and technical reports on systems, products and processes · Continuous improvement of GMP compliant requalification and calibration systems based on current industry principles and regulatory requirements · As DI Single Point of Contact (SPOC) to: o act as liaisons between their respective departmental teams and the DI officer o ensure the regular DI Surveillance, e.g. by Gemba Walks and by performing internal DI moments, huddles, and trainings
· Planning and realization of system changes and plant improvements as well as developing and executing test programs · Supervision and maintenance of pumps in the department of mechanical engineering · Planning, coordination and execution of maintenance orders on mechanical systems (Components like valves, pumps, heat exchangers, reactor vessel internals, etc.) as well as on systems handling and solidifying radioactive waste · Procurement und management of spare parts · Coordinating and supervising outside companies and their personnel · Documenting and reporting in the context of plant and aging monitoring (e.g. trend analyzing and managing the maintenance data-base)