||Engineering and Manufacturing
||£50,000 - £55,000 per annum
Contact Shannon Mills to talk about this role on 01787 881962
Just Recruitment is seeking a Validation Manager on behalf of a company 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 three 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 Regulatory Requirements
- 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
- EHS: Ensuring compliance with safety, health and environmental (SHE) legislation
- Teamwork: Engaging with project teams to help with selection, installation and commissioning of new equipment Quality Assurance: 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.