Cardinale Karen

Develop Quality specifications and procedures to assure process, product, material, components quality. Perform activities related to creation of new and revisions to existing product labeling, manufacturing specifications, test methods, as well as abiding by change control processes to ensure that revisions made are in compliance with global regulatory regulations, business and customer expectations, and are properly justified and approved by responsible functional areas and are issued in a timely manner to support production. • Assesses planned temporary changes for possible impact. • Determines and executes required filing strategies to active product registrations • Works with Global Chemistry, Manufacturing and Controls (GCMC) Strategist as required • Assesses proposed changes to determine if CMC change management processes and system use is required • Identifies impacted and affected manufacturing sites and additional site signatures required for a change • Gathers and verifies required documentation as appropriate to support change • Coordinates site-to-site interaction including identifying impacted and affected manufacturing sites and their endorsement when required. • Creates Product Change Form (PCF) to support site changes with regulatory impact • Coordinates the dependencies between PDM and Change Management SOP • Resolve daily issues inherent to product specification and labeling. • Actively shares knowledge with others within Work Team through existing knowledge sharing processes/systems. • Manage multiple assignments and meet all required timelines. • Demonstrate proficiency on pDocs Document Management System. • Identifies and makes improvements to existing work processes/products • Updates records in PDM as required

Review all VCR packages for errors and remittance, make charts for management review board each month, keep up with all VCRs that are closed/opened to verify numbers for the management review board, and others when necessary, also all PPQs, PRs, and CA/PAs, update VCR listing daily, work with personal from all areas of Hospira, attend daily lot release meeting, take care of all aspects of shutdown as needed from validation department, take care of VCRs, change notices, Document change orders, change request, and any other aspects of validation that is necessary, answer phone, and all other duties as needed