Sr Specialist Qa – (29815)

Descripción del Empleo:
In support of Client’s Quality Assurance program acts as the technical specialist. Review and approve product MP’s. Approve process validation protocols and reports for mfg. Processes. Represent Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Own site quality program procedures. Designee for QA manager on local CCRB.

Doctorate degree and 2 years of directly related experience or master’s degree and 6 years of directly related experience or Bachelor’s degree and 8 years of directly related experience or Associate’s degree and 10 years of directly related experience.
Requisitos:
Doctorate degree and 2 years of directly related experience or master’s degree and 6 years of directly related experience or Bachelor’s degree and 8 years of directly related 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.