Qa Specialist-Parenteral Mfg-Process

Descripción del Empleo:
Perform one or more of the following duties and responsibilities in support of Company’s Quality Assurance program under minimal supervision. 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:
Minimum 5 years of experience in a regulated environment. Experience in Parenteral Mfg. Experience working with Processes Characterization, Environmental Qualification and Process Development. Bachelor Degree in Science or Engineering Completed. Fully bilingual. Must be available to work 1st, 2nd and 3rd shift. Qualified candidates please send resume to: **********