Sr. Specialist Qa

Descripción del Empleo:
General understanding on Manufacturing Execution System (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. Ability to conduct GMP quality inspections, walk downs and general oversight to production utilities and general facility areas with the objective to ensure the required state of Validation. Experience conducting quality audits to GMP production batch records and related supporting documents.
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.