QA Validation Specialist
Company
Location
Alnwick, England, United Kingdom
Posted At
7/3/2025
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Description
At Arcinova we accelerate the development of new medicines by integrating science, innovation, and people. We’re looking for a Validation Lead to join our Alnwick team and ensure our facilities, equipment, and computerised systems remain compliant, efficient, and inspection-ready.
The Role
As the owner of the Alnwick Site Validation Master Plan, you’ll play a pivotal role in maintaining our GxP compliance and driving validation excellence across the site. You’ll collaborate closely with Operations and Quality teams to ensure validation activities meet both regulatory expectations and Arcinova global standards.
What You’ll Do
The Role
As the owner of the Alnwick Site Validation Master Plan, you’ll play a pivotal role in maintaining our GxP compliance and driving validation excellence across the site. You’ll collaborate closely with Operations and Quality teams to ensure validation activities meet both regulatory expectations and Arcinova global standards.
What You’ll Do
- Lead and maintain the site’s Validation Master Plan.
- Review, approve, and author validation documentation for facilities, utilities, equipment, and computerised systems.
- Provide expert guidance on validation strategy, change control, and incident management.
- Conduct periodic reviews and data integrity assessments of validated systems.
- Support internal and external audits, and drive continuous improvement in validation processes.
- Train and mentor QA and operational staff in validation best practices.
- Prioritise and coordinate QA validation workload across the site.
- A degree in Life Sciences and 5+ years’ experience in validation within a GxP environment (GLP, GCP, or GMP).
- Proven expertise in validation standards such as 21 CFR Part 11, GAMP, and Eudralex Volume 4 Annex 11.
- Strong communication, decision-making, and problem-solving skills.
- A collaborative mindset with a focus on customer service and internal stakeholder engagement.
- Experience in line management and process improvement.
- Proficiency in Microsoft Office tools.
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