About the role
AI summarisedThe Specialist Quality Assurance will provide oversight and leadership for quality systems execution and operations support, supporting manufacturing operations and IPC testing through floor presence, as well as assisting with complex manufacturing investigations, change control, and unexpected result investigations.
BiotechOnsiteQuality
Key Responsibilities
- Provide oversight and leadership for quality systems execution
- Offer operations support to manufacturing processes
- Support IPC testing through presence on the production floor
- Assist with complex manufacturing investigations
Requirements
- Amgen Quality Management System in plant operations through phases of commissioning, process qualification, regulatory approval and market supply Support routine GMP documentation review activities (e.g.
- Win What we expect of you Basic Qualifications Doctorate degree OR Master’s degree and 2 years of directly related experience OR Bachelor’s degree and 4 years of directly related experience OR Diploma and 8 years of directly related experience 8 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical / biologics industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems.
- Direct experience with bulk manufacturing of biopharmaceuticals/API preferred.