Validation Manager

Just Recruitment Group Ltd
Sudbury, UK
14 Sep 2019
22 Sep 2019
Contract Type
Full Time
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

Ensuring compliance with safety, health and environmental (SHE) legislation

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.
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