Job Description

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 agency guidelines, industry association guidelines and good practices ⚫ Manage complaint program and monitoring for trends, coordinate requirements of investigation from site when required ⚫ Manage annual product review reporting which includes compiling data for reports and completion of each report (adhering to schedule for APR Execution) Document Control Systems (30%) ⚫ Site owner and subject matter expert for the management of GMP documentation, change control and CAPA systems ⚫ Manage the document change control processes that involve the receipt, maintenance, approval, distribution, maintenance of files and storage of documents to include, but not limited to: batch records, standard operating procedures, protocols, deviations, investigations and standard forms. Training/Coaching (30%) ⚫ Develop and implement a standardized training process that complies with all regulatory/corporate requirements (GMP focus) by working with site functional leads, Quality CoE Training & Capabilities Manager, Corporate QA, and training peers to develop processes, tools and templates to deliver a standardized approach ⚫ Establish training curriculum and assignments based on assigned functions in collaboration with site leadership and Quality CoE Training & Capabilities Manager ⚫ Develop and deliver site level GMP training for new employees and re-fresher trainings as required ⚫ Develop, maintain and report appropriate training metrics