Specialist Qa

Descripción del Empleo:
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:
Expertise in Quality Systems such as Non Conformance, CAPA and Change Control. Robust knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development. Exposure to 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.

Doctor degree Or Master’s degree and 3 years of Quality or Manufacturing experience in GMP regulated environment Or Bachelor’s degree and 5 years of Quality or Manufacturing experience in GMP regulated environment.