Hobson Prior is seeking a Validation Director for a permanent role based in Shannon. The successful candidate will be responsible for ensuring that the site Master validation plans reflect current regulatory requirements and are aligned with best practices. This role will be a key participant during site audits and inspections and will provide direction in relation to Validation and qualification Strategy to various departments. The role will require travel between London and Shannon.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities

• Ensure that the site Master validation plans reflect current regulatory requirements and best practices.
• Participate in site audits and inspections.
• Provide direction in relation to Validation and qualification Strategy to other departments.
• Support and guide the implementation of ICH Q9 Risk Management and ICH Q8 Pharmaceutical Development principles.
• Coach validation team members regarding validation/qualification best practices.
• Ensure the standard of completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
• Prepare and execute Gap analysis of all existing processes, computer systems, facility and equipment.
• Review Change controls and Issues to ensure that any Validation impact has been addressed appropriately.
• Prepare a revalidation strategy to address additional validation as applicable.
• Ensure compliance with GMP, Data Integrity and Good Documentation Practice (GDP).

Requirements

• Degree in Pharmaceutical Validation, engineering or Science discipline.
• Strong track record in delivering robust and regulatory compliant validation strategies in a commercial biotechnology manufacturing environment.
• Extensive experience of GxP compliance requirements.
• Excellent interpersonal skills.
• Ability to identify and escalate issues to line management.
• Experience in delivering the validation responsibilities on complex capital projects.
• Demonstrated track record of building and developing teams.
• Ability to use project planning software is desirable.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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