Sr Specialist Qa - Aseptic

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.
Requisitos:
Bachelor’s degree in Science or Engineering and 8 years of Quality experience
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.
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.
Knowledge on general Validation concepts (e.g. Process Performance Qualifications, Commissioning & Qualification and Validation Life Cycle Management for Equipment and Facilities including Computerized Systems) applied to GMP Pharmaceutical production areas required.