Job Description

This role will see you managing the validation programme across the business to ensure all systems, products and processes are compliant with regulatory requirements.
This business’s mission is to improve patient’s quality of life by creating state of the art products, driven by science.
In this position your roles & responsibilities will include:
• Development and maintenance of validation policies, standards and procedures
• Reporting metrics to monitor performance of the validation system
• Investigate and document non-conformities/protocol deviations
• Complete CAPA investigations and prepare reports
• Manage all validation activities (IA/FAT/SAT/IQ/VSRs/PQ/OQ)
• Identify compliance risks
• Develop SOPs and quality plans
• Support regulatory inspections and audits

Required Knowledge, Skills, and Abilities

• A degree (or equivalent) in engineering • Experience in a validation position within a GMP regulated environment • Working knowledge of cGMP, FDA 21 CFR Part 820 QSR and ISO:13485 • An understanding of statistical sampling techniques • Proven ability to present to FDA Inspectors, Notified body auditors and other regulatory functions