Sr Specialist Qa – (30242)

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.

Competencies/Skills:
Project management skills. Strong organizational skills, including ability to follow assignments through to completion. Initiate and lead cross functional teams.
Enhanced skills in leading, influencing, and negotiating. Strong knowledge in area of expertise. Collaborate and coordinate with higher level outside resources.
Requisitos:
Doctorate degree in Sciences/Engineering and 2 years of directly related experience or Master’s degree in Sciences/Engineering and 6 years of directly related experience or Bachelor’s degree in Sciences/Engineer 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.
• Capable to review and approve complex GMP documents from a Quality standpoint to ensure adherence to company policies, operating