SEKISUI Diagnostics are looking to appoint a dedicated and experienced QA Validation Manager, to join our Quality Assurance team on a full-time basis. This key position reports directly to the Head of Quality and plays a vital role in guiding a high-performing team committed to securing cGMP certification for the organisation. The ideal candidate will be responsible for leading the design, execution, and continuous improvement of validation systems and processes. This includes recruiting and mentoring members to ensure optimal performance and operational excellence within the function. The responsibilities for this role include, but are not limited to: Co-ordinating and performing validation project activities for all facilities, equipment and processes operated in compliance with EurdraLex Volume 4 - Good Manufacturing Practice (GMP) guideline requirements and other applicable quality system requirements Establishing and maintaining best practices for departmental procedures to ensure effectiveness to validation requirements Providing direction and expertise in the management of validation activities Preparing, executing and reporting validation protocols Rationalise validation documentation (and protocol requirements) to ease routine validation activities while validation requirements are met Liaise with Engineering, Quality Assurance and User Departments to ensure that validation is conducted in a timely manner with minimal disruption to production Maintaining an awareness of regulatory developments in the validation field and brief Kent Operations personnel as appropriate Attend meetings, both internal and external, representing the department in a professional manner Ensure review and update of validation procedures (Policies, Master plans, Standard Operating Procedures (SOP’s) etc.) for equipment and facilities Participate in audits by customers and regulatory authorities This job is fully qualified, career-oriented, and journey-level position. Typically requires a scientific university degree and a minimum of 10 years of validation and GMP related experience. The successful candidate should have Specific knowledge of EudraLex Volume 4, including validation requirements in Annex 11
