Working location:Ibaraki Major Duties: As part of an extended team, ensure operational excellence and every day great execution (EDGE) across area of responsibility (facilities, warehousing, compounding, fill and assembly), safely, efficiently, and effectively optimizing performance through
Working location: Ibaraki Policies, Procedures and Standards (40%) Implement and enforce policies, procedures and standards Conduct internal site audits, document audit results and ensure site audit preparedness Maintain knowledge and understanding of applicable GMP regulations, regulatory
Position Summary & Job Description Ensure that all operation systems design, implementation and execution are compliant with applicable validation, cGMP, and regulations and requirements across Kujira campus. Areas of responsibility cover facilities and utilities, DQ,
Coordinate all activities, within the Plant, which are part of the Plant Validation Program. This includes timely completion of validation protocols, working with relevant departments to ensure people are aware of, and understand, the validation process
Position Summary & Job Description As part of an extended team, ensure EDGE (day great execution) through collaboration in theverye development of optimal standards and routings for new and updated products, participate on FMEAs and commercialization