Manager Validation

Sekisui Diagnostics, LLC; Maidstone; Presencial; GBP 85 000 - 110 000; Tempo integral

Resumo da oferta

SEKISUI Diagnostics is seeking a dedicated QA Validation Manager to lead the validation function within our Quality Assurance team. This full-time role reports to the Head of Quality and drives cGMP compliance across facilities, equipment and processes.

You will design and execute validation protocols, mentor staff, and ensure timely, well-documented validation activities while staying current with regulatory changes such as EudraLex.

Qualificações

• Typically requires a scientific university degree and a minimum of 10 years of validation and GMP experience.
• Strong knowledge of EudraLex Volume 4 and Annex 11 & 15.
• Experience in managing people and leading validation activities.

Responsabilidades

• Coordinate and perform validation activities for facilities, equipment, and processes.
• Prepare, execute and report validation protocols.
• Maintain validation documentation and SOPs.
• Liaise with Engineering and QA to ensure timely validation with minimal production disruption.
• Support audits by customers and regulatory authorities.

Conhecimentos

Leadership

Validation expertise

GMP knowledge

Formação académica

Scientific university degree

Descrição da oferta de emprego

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 & 15
• Experience in managing people
• Ability to author and execute validation reports

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.

As 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.

Only those candidates who are selected for further consideration or interviews will be contacted by a member of the company’s internal recruiting team.