South West London
£60,000 - £80,000
An exciting opportunity has arisen for a Validation Manager to join our client who is a well-established healthcare business.
The Validation Manager will be tasked with:
- Developing, implementing and managing a business validation strategy ensuring that all equipment, facilities, cleaning, processes, and computer systems used for GxP purposes are qualified and are fit for their intended use in accordance with cGMP guidelines and GAMP.
- To lead the Validation team; providing expert knowledge, support, and input into individual equipment, cleaning, process, laboratory method, and computer systems validation projects and ensure that there are sufficient resources available.
- To develop all policies, procedures, and templates required to support validation activities. Identify gaps, trends, or new regulatory requirements related to validation and formulate remediation proposals.
Key Responsibilities / Duties
- Provide expert knowledge, input, and support regarding validation activities.
- Lead the Validation team, providing expert support and guidance, and identifying and supporting training and personal development needs of the team.
- Develop, implement, and manage the business validation strategy, and ensure short and long term plans for the execution of the strategy and remediation of identified gaps and risks.
- Design, develop, implement, and train out policies and procedures related to equipment, cleaning, process, laboratory, and computer systems validation.
- Ensure that all equipment, facilities, cleaning, processes, and computer systems used for GxP purposes are qualified and are fit for their intended use in accordance with cGMP guidelines and GAMP
- In agreement with the Quality Assurance team, develop and define business quality standards for validation activities.
- Monitor regulatory and industry expectations for validation activities and take appropriate action.
- Define and continuously review validation KPI’s and to present regular updates to site management regarding performance and validation status, gaps, and risks.
- Manage, oversee, and perform validation programs and activities.
- Write, review, or approve validation plans, protocols and reports.
- Ensure that a high and consistent standard of record keeping is maintained for all validation activities.
- Maintain current a site validation master plan using a risk based approach.
- Provide validation guidance to cross-functional teams.
- Assess validation requirements for new product, equipment, or process introductions and ensure timely planning and support to their implementation.
- Assist with regulatory inspections, to provide clear explanations for validation activities, protocols, and reports.
- Degree of equivalent in a scientific discipline or qualified by experience.
- Extensive validation and/or Quality Assurance experience
- Significant validation management experience in a cGMP environment.
- Thorough understanding of cGMP validation regulations and guidelines including Eudralex Volume 4, 21 CFR 211, GAMP 5, and ICH
- A seasoned professional, able to work at both a strategic and hands-on level, and able to act as a subject matter expert for the company regarding validation.
- Proven project and people management experience.
- Pharmaceutical or regulated healthcare/ FMCG experience.
- Knowledge of pharmaceutical equipment and computer systems requirements.
- Ability to motivate, to lead, and manage staff.
- Excellent influencing skills with personnel at all levels in the company.
- Experienced in leading and delivering multiple validation projects simultaneously.
If you are interested in applying for this role please click apply now!
Harris Lord is acting as an employment agency for this role.
Keywords: validation, manager, GAMP, GXP, GMP, FDA, Eudralex, cGMP, Pharmaceuticals, Medical Devices, Pharma,
Contact: Josh Hemsley
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