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Csv analyst

Dublin
emagine Group
Analyst
Posted: 20 August
Offer description

Join to apply for the CSV Analyst role at emagine6 days ago Be among the first 25 applicantsJoin to apply for the CSV Analyst role at emagineResponsible for ensuring that computerized instrument systems are in full compliance with regulatory requirements, company policies and procedures and will drive improvements in line with regulatory changes (including but not limited to 21 CFR Part 11, EU GMP Annex 11 and Data Integrity Guidance).Provide technical oversight for computerised instrument validation (CSV) processes, in accordance with site and corporate procedures and GMP guidelines. The activities include, but are not limited to; the oversight for Validation Plans and Strategies, Risk Assessments, Requirement Specifications, Testing, Data Migration, SOPs, Change controls and Deviation Investigations.Manage, co-ordinate, develop and execute computer system validation deliverables for new and existing projects. This includes development and management of project plans, prioritizing validation activities in line with the overall project schedules.Liaise with vendors to design and deploy computerised instrument solutions to integrate with existing onsite IT services & infrastructure (backup, database, patching etc).Participate in and support audit activities.Participate, contribute and report at team meetings.Responsibilities:Responsible for ensuring that computerized instrument systems are in full compliance with regulatory requirements, company policies and procedures and will drive improvements in line with regulatory changes (including but not limited to 21 CFR Part 11, EU GMP Annex 11 and Data Integrity Guidance).Provide technical oversight for computerised instrument validation (CSV) processes, in accordance with site and corporate procedures and GMP guidelines. The activities include, but are not limited to; the oversight for Validation Plans and Strategies, Risk Assessments, Requirement Specifications, Testing, Data Migration, SOPs, Change controls and Deviation Investigations.Manage, co-ordinate, develop and execute computer system validation deliverables for new and existing projects. This includes development and management of project plans, prioritizing validation activities in line with the overall project schedules.Liaise with vendors to design and deploy computerised instrument solutions to integrate with existing onsite IT services & infrastructure (backup, database, patching etc).Participate in and support audit activities.Participate, contribute and report at team meetings.This role is 5 days a week onsite in the Limerick office.Key Requirements:Bachelor’s Degree (Level 8) in Information Technology, Computer Science, Engineering or related field.Minimum of 3+ years of experience in a pharmaceutical or other regulated industry.Extensive knowledge and experience in development and execution of Computer system validations.Extensive understanding of regulatory requirements associated with CSV, including ER/ES(21CFR Part 11), security, and data integrity.Demonstrated initiative to build relationships, learn new business processes and identify opportunities.Influencing skills and the ability to work in cross-functional team environments, as well as independently.Analytical and problem-solving skills.Excellent communication skills.Nice to Have:Experience in administration of computerised lab equipment.Experience of quality control laboratory IT systems (i.e. Empower, Lab Vantage, etc.).Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionBusiness Development and SalesIndustriesIT Services and IT ConsultingReferrals increase your chances of interviewing at emagine by 2xSign in to set job alerts for “Analyst” roles.Dublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 4 days agoDublin, County Dublin, Ireland 5 days agoDublin, County Dublin, Ireland 2 days agoDublin, County Dublin, Ireland 19 minutes agoDublin, County Dublin, Ireland 5 minutes agoDublin, County Dublin, Ireland 4 weeks agoDublin, County Dublin, Ireland 3 days agoDublin, County Dublin, Ireland 3 days agoCustomer Growth Associate, Google Customer Solutions, Early Careers (English)Dublin, County Dublin, Ireland 2 weeks agoDublin, County Dublin, Ireland 2 hours agoDublin, County Dublin, Ireland 5 days agoDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 2 days agoDublin, County Dublin, Ireland 3 days agoDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 2 weeks agoDublin, County Dublin, Ireland 2 weeks agoDublin, County Dublin, Ireland 4 days agoDublin, County Dublin, Ireland 6 days agoDublin, County Dublin, Ireland 3 days agoDublin, County Dublin, Ireland 3 weeks agoDublin, County Dublin, Ireland 3 days agoDublin, County Dublin, Ireland 6 days agoDublin, County Dublin, Ireland 2 weeks agoDublin, County Dublin, Ireland 5 hours agoDublin, County Dublin, Ireland 3 days agoDublin, County Dublin, Ireland 5 hours agoDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 5 hours agoDublin, County Dublin, Ireland 2 weeks agoDublin, County Dublin, Ireland 3 days agoWe’re unlocking community knowledge in a new way. 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