OneAPPS Consulting (www.oneapps.com) is a Technology consulting firm based out of Switzerland and offices across Europe. We are working on various projects involving diverse, multicultural teams with clients across the Europe. We are an invaluable partner and our teams have collaborated to support the growth of our clients. With more than 7 locations worldwide we help our clients to deliver their projects smoothly. We look forward to getting to know you and working with you.Job Description:Candidate should have experience to below areas in practicalHave managed working in the Ops and should have real time experience working on mfg. sites.Handling Application Qualification of OT systems at complex or specialty manufacturingFair Understanding on Data Migration PrinciplesFair Understanding on Information Security and SOX ComplianceFair Understanding on risk-based methodologies in driving the projects from Quality and Compliance POVInformation Security and SOX ComplianceCandidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.Candidate will be accountable for:Authoring various Qualification and Validation deliverablesHandling of defects/DeviationsInvestigationsCAPA HandlingTest Management & ComplianceCandidate must have fair conceptual understanding on below key areasIT QMSValidation/QualificationRisk management.Candidate must be having user friendly experience with Kneat, HP ALM, Kneat and SNOW as toolOT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus)PAS/DCS QualificationISA95 understandingOT Security will be a plus.Standalone Systems QualificationsPAS/DCS Integrated with Manufacturing Equipment qualification. Essentials / DesirableProfessional experience and strong knowledge with real time experience in areas stated aboveIT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry.Well versed with Manufacturing, Quality and engineering system and their validationsStakeholder management and good executor with required communication.Knowledge of Pharmaceutical / Life Sciences as domain.Experience to MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc. will be an advantageIf this role sounds like you, we invite you to apply. Thanks.Due to work permit restrictions, we can only consider applications from UK, EU citizens as well as current work-permit holders for Spain.