Senior QA Validation Specialist

About the role

Regeneron, a science-driven company developing medicines for people with serious diseases, is looking for a Senior QA Validation Specialist to join its Quality Assurance team in Raheen, Limerick. Some travel may be required. The role supervises the end-to-end qualification of equipment and drives a quality culture and compliance with manufacturing standards.

Key responsibilities

• Supervise the end-to-end qualification process so that each piece of equipment is fit for its intended use and contributes to the 365 inspection readiness programme
• Foster and implement a quality culture and company manufacturing standards, policies and procedures
• Schedule, execute, review and approve qualification activities
• Assess executed change controls and deviations for their impact on the qualified state and conformance to regulations, SOPs and specifications
• Investigate and troubleshoot problems and recommend changes or improvements
• Review, edit and approve deviation notifications, investigations, corrective actions, change controls, SOPs, reports and other documentation
• Coordinate with other departments and outside contractors or vendors to complete validation tasks
• Manage and drive projects, and supervise less experienced full-time employees and contingent workers to meet goals and deadlines

Required profile

• BS/BA in Engineering, Chemistry or Life Sciences, with 5-8+ years of proven experience in the field (relevant experience may substitute for education)
• Previous experience as a subject matter expert in a highly regulated environment (pharma, biotech, medical devices) in internal and external regulatory audits
• Strong background in site change controls, risk management and data integrity programmes
• Project management experience

Required skills

• Expert knowledge of EU Annex 11 and FDA 21 CFR Part 11
• Strong knowledge of data integrity
• Knowledge of equipment used for QC analysis and operations
• Ability to work independently or in a team, communicate transparently and prioritise multiple tasks

The salary range is EUR 54,200 to EUR 88,400 per year. The role is on-site, and background checks may be carried out as part of the recruitment process.