Specialist Qa – (29814)

Descripción del Empleo:
Perform one or more of the following duties and responsibilities in support of Client’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:
Doctorate degree or Master’s degree and 3 years of Quality experience or Bachelor’s degree and 5 years of Quality experience.

•Engineering / Science related background.
•Experienced in Aseptic processing manufacturing processes.
•General understanding on Manufacturing Execution Systems (MES) and electronic Batch Records (e-BR).

Experience working on GMP regulatory and compliance manufacturing environments with a strong Quality mindset in the production of aseptically produced sterile biological drug products.
•Direct experience on Quality related matters associated to the GMP sustainability of pharmaceutical production areas.
•Capable to review and approve complex GMP documents from a Quality standpoint to ensure adherence to company policies, operating standards, procedures and/ or the applicable GMP document or project plan.