Senior IT Validation Professional

Job title:

Senior IT Validation Professional

Company:

Roche

Job description

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.The PositionWe are looking for a Senior IT Validation Professional who has:Minimum 6+ years experience in IT & Software Validation (CSV, GAMP5) including:Leading validation for projects and systems maintenance,Authoring validation plans, reports and deliverable registriesReviewing validation and testing related deliverables, records and other evidences, including relevant system documentationMaintenance and support of applications under global audit and inspection agencies, good knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11,EU GMP Annex 1, GxP practices)Good understanding of system and data risk assessmentAbility to work collaboratively in cross-functional and agile teams to achieve milestones and goalsEffective communicator with excellent verbal and written communication skills – English language mandatoryAssertiveness, conflict management skills, leadership skills and ability to work with diverse personality/culturesGeneral understanding on Agile Methodology(Framework (i.e SAFe, Scrum), previous experience would be an advantage.Bachelor of Science or equivalent in computer science, engineering, life sciences, or related fieldLet’s find out what a usual day of work might look like. You will:Determine validation approaches, identifies deliverables needed or impacted by a project / enhancement / change for GxP computerized systemsBe responsible for the review of system documentation according to the Roche CSV SOPs and regulatory guidanceDevelop validation plans/reports, reviews test plans/reports (and other deliverables), and assess, authorize and notify that the system is ready to go liveVerify testing plans, activities, deliverables and records, provide consultancy on test related deviations and corrective actions according to approved proceduresSupport in deviation investigations to identify root causes and define corrective and/or preventative actionsSupport system audit/inspection preparation and execution as CSV subject matter expertSupport system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection readyLead and author system periodic reviews according to company procedureImplement relevant framework and processes, proposes and uses toolsProviding training and validation/quality knowledge/experience exchange supportPrepares recommendations for process optimization in his/her area of influenceWe offer:dedicated training budgets and many opportunities for personal and professional self-development (training, conferences, diversified career paths, etc.)a workplace that supports innovation and new ideasattractive benefits & business travel opportunitieswork in a great team with international colleagues on exciting topics to shape the IT behind the healthcare of tomorrowInterested? APPLYRoche is an equal opportunity employer. We care about inclusion in terms of gender, age, race, skin colour, nationality, religion, marital status, sexual orientation, background, physical or mental disabilities and on every other grounds. Applying for our position, we assure you that we will assess your application solely on the basis of your competencies.Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Roche is an Equal Opportunity Employer.

Expected salary

Location

Madrid

Job date

Tue, 13 Aug 2024 22:24:03 GMT

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