About the role
AI summarisedThe QA Operations Senior Specialist at Thermo Fisher Scientific is responsible for maintaining GMP compliance across manufacturing, engineering, and warehouse operations. This role involves quality monitoring, audit readiness, deviation investigations, and supporting quality systems under the guidance of a QA Manager. The position requires a rotating 12-hour shift and 4-6 years of relevant pharmaceutical quality experience.
Life SciencesOnsite
Key Responsibilities
- Follow site safety requirements and maintain a safe working condition during daily operations
- Provide shop floor QA supervision and problem-solving support to manufacturing operations, ensuring routine compliance
- Perform Quality Monitoring for aseptic manufacturing processes and Acceptable Quality Checks for sterile products
- Coordinate quality in microbiology, including vial reading for incubated media-filled vials
- Support QC area by reviewing QC documents and participating in operational readiness programs
- Assist QA manager with batch disposition and review validation documents, including computer system validation
- Assess incoming materials for new product introductions and write operational procedures, reviewing all SOPs
- Collect and analyze shop floor information, working with operations to resolve issues as a QA representative
- Ensure all-time readiness for GMP and client audits, participating in deviation and OOS investigations
- Lead root cause analysis with effective CAPA and support process validation, clean validation review, and approval
- Establish and improve QA Operations procedures to enhance quality and efficiency continuously
Requirements
- Bachelor’s Degree or equivalent experience in Life Sciences, Chemical/Biochemical Engineering, or a Pharma-related Scientific Area
- 4-6 years of relevant Quality experience in Pharmaceuticals/Biopharmaceuticals
- Experience in Quality Management Systems
- Experience in quality operations
- Experience in biologics/aseptic training