Oversee the site Master Validation Plan, using inputfrom internal and external resources for continuousimprovement. Creates, coordinates, and enforcesValidation systems, policies, and proceduresResponsible for periodic assessment and requalificationprogram, PPQ (Process Performance Qualification)Cleaning and CV (Computer System Validation)Manage validation department personnel; hire, train,coach, and develops staff within the Validation teamMonitor the performance of the validation departmentby tracking appropriate metrics and reporting the resultsto management.Responsible for the day-to-day activities conducted bythe Validation Department; establishes priorities toensure that deadlines are met and budgets are notexceededLiaise with outside vendors as a representative ofvalidation and supervises the activities of externalvalidation contractorsOversee development and approval of Validation SOPsand validation-specific documentsSupport commissioning activities, projects, andvalidation functions by performing, preparing andreviewing/approving validation protocols and otherdocumentation. Generate validation final reports asneededAct as the Validation SME for manufacturing operationsAssess change controls with an accurate understandingof the bigger picture implications of changesCommunicate validation activities and schedules toother departments as requiredWork closely with cross functional teams to ensure allwork is completed to high quality in a timely andscientifically rigorous manner

QA and Validation senior specilist (for cleaning validation, process validation and Qualification)