OneMain Financial Jobs

Responsibility/Authority

• Conduct validation activities in compliance with Regulatory standards and requirements and Precision Edge Surgical procedures
• Develop validation documentation as required (e.g. plans, protocols, reports, procedures)
• Execute validation protocols as required (e.g. Equipment IQ/OQ, Process OQ, Process PQ, etc.)
• Prioritize qualification activities in line with the project schedule
• Coordination, implementation and active participation in the site validation program for product, process, equipment, software, methods, utilities / facilities and cleaning
• Provide input into all project phases (i.e. from design through to the commissioning and qualification execution phases of the project)
• Assist in the evaluation of the validation statues of contract manufacturers and provide guidance where needed. Review and approval of documents prepared by the validation team, other departments and contractor organizations (e.g. commissioning test plans, impact assessments, change controls)
• Resolve and assist in the closure of deviations initiated during qualification / validation execution
• Initiate and implement change control activities in accordance with Precision Edge Surgical procedures
• Co-ordinate re-validation activities
• Generate procedures / other documentation as applicable
• Conduct training in validation methodologies and related procedures as required