Specialist Qa - 33042

- Review and approve product MPs. - Approve process validation protocols and reports for manufacturing processes. - Request Quality on incident triage team.- Approve Environmental Characterization reports.- Release of sanitary utility systems.- Approve planned incidents.- Represent QA on NPI team.- Lead investigations.- Lead site audits.- Own site quality program procedures.- Designee for QA manager on local CCRB.- Review Risk Assessments.- Support Automation activities.- Support facilities and environmental programs.- Review and approve Work Orders.- Review and approve EMS/BMS alarms.- Approve NC investigations and CAPA records.- Approve change controls.- Provide lot disposition and authorize lots for shipment.Requisitos:You will perform review, approval and tracking of cGMP processes, procedures, testing (methods) in manufacturing, documents and records, batch record review, MES, EBR, SAP, Trackwise; including but not limited to Deviation's, CAPAs, and validations.Actively engage in Continues Improvement initiatives, programs and projects.Vigilant ensuring that changes that could potentially impact product quality are assessed according to procedures.Certify that deviations from established procedures are investigated and documented per procedures.Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements.Validated experience as Quality Contact for complex projects involving packaging, inspection, and new products.