Manager Validation

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.ResponsibilitiesCo-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 requirementsEstablishing and maintaining best practices for departmental procedures to ensure effectiveness to validation requirementsProviding direction and expertise in the management of validation activitiesPreparing, executing and reporting validation protocolsRationalise validation documentation (and protocol requirements) to ease routine validation activities while validation requirements are metLiaise with Engineering, Quality Assurance and User Departments to ensure that validation is conducted in a timely manner with minimal disruption to productionMaintaining an awareness of regulatory developments in the validation field and brief Kent Operations personnel as appropriateAttend meetings, both internal and external, representing the department in a professional mannerEnsure review and update of validation procedures (Policies, Master plans, Standard Operating Procedures (SOP\’s) etc.) for equipment and facilitiesParticipate in audits by customers and regulatory authoritiesThis 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.QualificationsSpecific knowledge of EudraLex Volume 4, including validation requirements in Annex 1, 11, 15 and Biopharmaceutical cleaning validation.Experience in managing peopleAbility to author and execute validation reportsIf this sounds like you, please apply for immediate consideration.At SEKISUI Diagnostics, we help improve patient outcomes by doing what we\’ve always done – focusing on innovating and developing highly accurate diagnostics tests, reagents and systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. We will continue to embrace change and challenge new frontiers so that we can create unique, high-quality products and services that will leave our customers truly satisfied. With worldwide state-of-the-art manufacturing facilities and an international sales and distribution network, we are a solid partner for healthcare professionals, distributors, and manufacturers around the world. Our global capabilities allow us to meet the specific needs of our wide range of customers – and customize solutions at both a regional and product level.SEKISUI Diagnostics Offers a Competitive Compensation And Benefits Package.Equal OpportunitiesAs an equal opportunity employer, SEKISUI Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, colour, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, other non job related characteristics or other prohibited grounds specified in applicable country and local laws. It is also SEKISUI Diagnostics policy to comply with all applicable country and local laws respecting consideration of unemployment status in making hiring decisions.SEKISUI Diagnostics is pleased to consider all qualified applicants for open roles and encourages candidates to apply online.Only those candidates who are selected for further consideration or interviews will be contacted by a member of the company\’s internal recruiting team.#J-18808-Ljbffr