Specialist Qa

Descripción del Empleo:
Perform one or more of the following duties and responsibilities in support of 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:
Doctorate degree or Master’s degree & 3 years of directly related experience or Bachelor’s degree & 5 years of directly related experience / preferably in Science (Microbiology, Biology, Chemistry, Biotechnology), with at least 5 years of experience in the pharmaceutical or biotechnology industry

Experience in electronic batch record review; experience with isolator technology; able to take decisions related to quality events; experience in visual inspection of filled product; willing to work non-standard shifts; able to gown in support to routinely work at controlled rooms; perform aseptic processing audits; perform quality oversights of facilities, process, and personnel; approve quality deviations; experience in regulatory audits; presentation skills, written skills to issue daily reports