Validation Manager

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North West England | Ref: BBBH12590

£50000.00 - £55000 per annum + Benefits

Role Title

Validation Manager - Pharmaceuticals

North West

£53,000 + Bonus + Benefits

 

Role Profile

To manage and support validation activities across all functions with a key emphasise on providing expertise in all aspects of computer system validation and technical support.

Manage and maintain the Validation Master Plan (VMP) and associated validation matrix in accordance with GMP. Manage the execution of all validation related activities, including computer software validation, process validation, facilities and equipment validation.

Author, review and approve validation and technical documentation. Act as the QA change owner for all GxP systems, including risk identification and mitigation, responsible for tracking changes through to completion.

Recommend and manage corrective and preventive actions (CAPAs) to improve compliance.

Provide technical/validation support to production to maintain GMP and production efficiency. Complete risk assessments and documentation as required to ensure that the production equipment and production facilities comply with GMP and the relevant HSE guidelines.

Maintain compliance with Data Integrity Regulations, GAMP standards, 21 CFR Part 11 and applicable regulatory guidelines.

Produce and maintain Standard Operating Procedures.

Manage the validation team.

Track competencies of the Validation team. Provide leadership and development as required to achieve the business goals.

Undertake performance reviews for the Validation team in line with the company procedures, including absence reviews, disciplinary and grievance hearings.

Undertake other reasonable duties as agreed with the Head of Quality.

 

Client information

International Pharmaceutical manufacturing and distribution organisation based in the North West.

Remuneration

£52,000 + Bonus + Benefits

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