Thermo Fisher Scientific
,
Cramlington, Northumberland
QA Team Lead
Overview
Job Description
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com. Quality Assurance Team Leader We are recruiting for a QA Team Leader at the Cramlington site to increase the size of the Quality team in line with the new expansion project. The role: * Lead QA team to meet QMS requirements and batch release priorities * Provide and coordinate QA support to internal and external customers * Manage Product Batch documentation and final product release * Manage QMS - change control, CAPA, deviations etc. * Oversee QA approval for documents * Conduct and review internal audits * Lead onsite customer audits * Coordinate completion of quality questionnaires and responses to customer queries * Lead Site CAPA review board * Perform QA approval on validation protocols and ensure compliance to GMP/ISO standards The person: * Strong experience in a QA role * Experience of supervising a team * Able to lead root cause investigations * Excellent attention to detail and data analysis skills * Able to work to strict deadlines under pressure * Excellent IT skills in MS Office and Oracle * Self-assertive and able to manage projects and drive continuous improvement * Good communication skills * Willingness to learn 37.5 hours per week, 9.00-5.00 Monday to Friday Flexibility is expected around site shifts and requirements Salary up to 30k, depending on experience Employment Type: Full time