IT Validation Specialist (12 Months)

Eurofins Lancaster Laboratories

Waterford, Tipperary, Cork , Munster

Consider joining Eurofins Lancaster Laboratories where people are the most important element in our business. Eurofins Lancaster Laboratories is a leading contract lab that provides testing and research services in the environmental, pharmaceutical, and biopharmaceutical sciences to clients worldwide. We are currently seeking an IT Validation Specialist to join our Quality team on a 12 month contract. The primary purpose of this role is to lead IT, computer system validation and equipment & instrumentation qualification activities for a pharmaceutical contracting testing laboratory, this person will be a key point of contact for IT and Validation/Qualification activities on a day-to-day basis. Responsibilities. Access IT systems for Data Integrity vulnerabilities (File Level security, OS lockdown, Application Control. Develop a robust Data Integrity lockdown, backup strategy for GxP critical systems. Prepare the laboratory Validation Master Plan with regard to facilities, computer systems, equipment and instrumentation. Laboratory SME (Subject Matter Expert) on computer system validation and Data Integrity Requirement compliance. Write and/or perform evaluations, reviews, risk assessments and testing for laboratory computerised systems considering the principles of GAMP5, namely, 21 CFR Part 11 EU Annex 11 and 15 along with Eurofins procedures. Maintain up-to-date listing of all relevant systems and their GxP functionality. Conduct GxP assessment for laboratory computer systems. Conduct GAMP Risk Assessment for laboratory computer systems including management of requirements Trace matrix (RTM. Develop Validation Summary Reports for laboratory computer systems validation projects. Stay current with client, EU and US FDA validation expectations, regulations, and requirements; interpret regulations and coordinate implementation into internal practices. Write and/or assist technical groups (equipment/Instrumentation SMEs) in writing User Requirement Specifications, change control and related documentation in accordance with established validation program. Write and/or assist technical groups (equipment/Instrumentation SMEs) in writing Work Instructions, Standard Operating Procedures in accordance with Data Integrity Requirement compliance. Implement quality systems and procedures in conjunction with management to direct the validation life cycle; maintain validation policies and operating procedures in a current compliant state. Review and approve documents ensuring GMP compliance, in-house procedure compliance completeness and consistency. Deliver training to technical group to ensure full understanding of the company validation requirements with emphasis on the content of the validation master plan, validation template documents, internal procedures and management of validation changes. What we are looking for? Bachelor’s degree in computer science, chemistry, biochemistry, microbiology or engineering. At least 3 years’ experience in IT and computer system validation support of pharmaceutical laboratory computer systems, equipment and instrumentation. Executed GAMP5 projects in pharmaceutical laboratory environment. Good team player, organised, accurate, have strong documentation skills. Passionate about IT, computer system validation and client service. Good communication skills both internally and externally. The ideal candidate will be highly motivated, high achiever with strong project management skills to develop clear project plans and to complete projects within agreed timelines. This job originally appeared on RecruitIreland.com.

2533 days ago