||Science and Pharmaceuticals
||£50,000 - £55,000
Contact Ellen Dalena to talk about this role on 01440 270011
Just Recruitment is seeking a Validation Manager for a company to be based at their Sudbury site.
You will be leading and inspiring the validation team as part of the extended site leadership and will be managing 3 direct reports.
You will also manage and support validation activities across all functions with a key emphasis on providing expertise in all aspects of process, equipment and computer system validation and technical support.
Your mission and responsibilities:
- Manage and maintain the Site Validation Master Plan and associated Validation Master Tracker in accordance with GMP
- Chair site Validation Review Board
- Preparation and execution of validation protocols. Author, review and approve validation, technical documentation and SOPs.
- Assisting system owners with impact assessments and identifying qualification/validation requirements
- Carrying out all validation activities on equipment
- Represent the business in customer audits and regulatory inspections to demonstrate that we have compliant systems
- Maintain compliance with Data Integrity Regulations, GAMP standards, 21 CFR Part 11 and applicable regulatory guidelines
- Ensuring compliance with safety, health and environmental (SHE) legislation
- Engaging with project teams to help with selection, installation and commissioning of new equipment
- Competent in the principles of and practical use of the Quality Management Systems
Your qualifications and experience:
- Extensive validation experience in medical product manufacturing industries
- Fluent in cGMP principles
- Thorough understanding of regulatory requirements for EMA ISO13485 and US CFR 820
- Thorough understanding of the principles of validation (e.g. V Model)
- Proven leadership skills in leading small to medium-sized teams
- Solid project management experience leading small to medium-sized teams in technical projects
Your personality and skills:
- Structured problem solving / investigation skills
Our client is a highly desirable company to work for offering a supportive and positive working environment, as well as the opportunity to undergo ongoing training in order to develop within the business.
In terms of package our client offers a highly competitive salary up to £55,000 plus extensive benefits.
For more information or to be considered for the role please apply today.