Sr Specialist Qa

Descripción del Empleo:
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. Enhanced skills in leading, influencing, and negotiating. Strong knowledge in area of expertise. Collaborate and coordinate with higher level outside resources. Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and processes development.
Requisitos:
Experienced in Aseptic processing manufacturing processes. General understanding on Manufacturing Execution Systems (MES) and electronic Batch Records (e-BR). 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. Excellent Technical Writing.

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.