Validation Manager

Sector: Science and Pharmaceuticals
Salary: £50,000 - £55,000
Location: Sudbury
Role: Full Time
Contract: Permanent
Job ref: 908172
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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 

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. 

For more information or to be considered for the role please apply today.

Contact Ellen Dalena to talk about this role on 01440 270011