Senior Computer System Validation Engineer required to Lead Quality, Compliance & CSV by innovative MedTech company in Galway

Responsibilities:

• Lead Quality and Compliance activities in relation to Software projects.
• Ensure Quality and Compliance with respect to Software/Computerised Systems projects.
• Support, guide and monitor projects, to ensure that approved software development standards, processes and procedures are adhered to, while also guiding the adoption of industry best-practices.
• Support supplier assessment for software system providers.
• Lead continuous improvement projects for Computerised System Validation / Assurance.
• Ensure that processes, SOPs and forms for computer systems control and validation continue to meet the requirements of relevant regulations and are fit for purpose.
• Quality review and author computer system validation documentation; change controls, test scripts, protocols, reports.
• Train, develop and manage SQA engineers to ensure objectives are communicated and delivered per the business requirements.

Requirements:

• BSc. Degree in Computer Science or Quality Assurance, or equivalent industrial experience
• At least 8 years’ experience working in a regulated device or pharmaceutical company of which at least five years must be within a quality assurance or related role.
• Understanding of ISO 13485 and FDA QSR quality standards, particularly 21 CFR Parts 11 & 820.
• Familiarity with GAMP5 Guideline for “Risk Based approach to GxP Compliant Computerised systems”.
• Familiarity with Agile/SCRUM practices for software implementation and product development.
• Ability to work within a team environment to achieve agreed company goals.
• Ability to communicate effectively with all levels of the company.
• Ability to meet deadlines and follow through on assigned deliverables.
• Attention to detail.