Job Description 39 Hours per week. Monday - Friday. 9am - 5pm. You will be supporting the operation and development of the Quality Management System within pharmaceutical finished products, API and raw materials. Administration of internal IT systems. Approval of procedures, protocols, reports and further approval of certificates of analysis. Support the resolution of quality issues. Management of quality KPI and metrics. Management of site communications on quality topics. Review and approval of calibration and qualification data. Support activities related to Metrology. Support activities related to stability studies. Completion of self-inspections. Support the compilation of information for client audits and regulatory inspections. Providing information to clients. Coordination of quality technical agreements. Administration and control of external documentation. Support the controlled substance process. Responsibility for CSV activities including computer system validation, validation plans, creation/review of validation protocols and reports, ERES assessments and the validation life-cycle.