About the role
AI summarisedJoin Thermo Fisher Scientific as a Senior Quality Operations Specialist responsible for accomplishing quality operational and compliance activities to maintain GMP compliance across shop floor, engineering, and warehouse areas. You will ensure site adherence to GMP requirements and corporate policies while driving continuous improvements in the quality system.
Life SciencesOnsite
Key Responsibilities
- 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.
- Assist QA manager with batch disposition and review validation documents, including computer system validation.
- Lead root cause analysis with effective CAPA and support process validation, clean validation review, and approval.
- Ensure all-time readiness of the site for GMP and client audits, participating in deviation and OOS investigations.
- Collect and analyze shop floor information, working with operations to resolve issues as a QA representative.
- 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 is required.