PD-ploy is an strongIT /strong and Engineering Solutions company with operations throughout the EMEA region including Switzerland, Germany, Czech Republic, Austria, UK, as well as the USA. /ppWe pride ourselves on delivering innovative and superior services and solutions to numerous industry-leading clients. By building relationships and trusted partnerships within the strongIT /strong community, we optimize our customer‘s strongIT /strong productivity and contribute to the organization’s success and value. /ppWe are interested in talking to engaging, flexible, and solution-oriented individuals who are looking to become a part of a dynamically growing and international organization. We are focused on creating value where strongIT /strong counts, join us! /p h3Tasks and Responsibilities /h3ul liPreparation and execution of computer-based system qualification deliverables (project plan, HLRA, URS, QPlan, IQ, OQ, PQ, ERES assessment and Verification, Q-Report, risk assessment, decommissioning test plan, SOP) in a pharmaceutical environment (laboratory, production) /li liReview of qualification deliverables generated by project team members /li liMigration of computer-based lab equipment systems (Operating System, Data etc.) /li liProvide help to onsite lab IT supporter in troubleshooting or system configuration specific topics /li liAssist the Service Coordinator and Service Delivery Manager in the delivery and project management processes required to complete projects within timeline and budget /li liSubject Matter Expert for qualification purposes and Point Of Contact for regulatory inspections and audits /li liSupport and deputize colleagues onsite /li /ulpstrongRequirements /strong /pul liBig pharma experience, document creation experience, GxP, and IO OQ PQ basic experience /li liWorking knowledge of qualification processes and Computer System Validation concepts /li liGood understanding of and motivation for working in regulated environments (GxP methodologies, 21 CFR Part 11 compliance, ALCOA+ principles and latest industry expectations for Data Integrity) /li liLab environment, ITIL and IT knowledge is an advantage /li liExcellent communication skills with client, 3rd party, project manager and team members /li liProven ability to prioritize and manage multiple demands, projects and cross-functional teams /li liExperienced in technical communication, which includes but is not limited to technical writing, instructional design, technical editing, copy, editing or proofreading and quality assurance /li liGood at gathering feedback and implementing improvements /li liSelf-responsible, self-organized and flexible person /li liMulti-tasking and handling changes in requirements or schedule /li liWillingness to work at different customer locations /li listrongFluent in English and German (spoken written) /strong /li liCandidates must provide Criminal record extract not older than three months /li /ulpstrongBenefits /strong /pul liBroad range of activities, tasks, and projects /li liLunch Checks or Reka Money (Lunch Checks can be used in 7000+ restaurants, Reka Money can be used for Transport Accommodation, Sport Wellbeing, Leisure Culture, Holidays Travel) /li liEnjoy free refreshments in our D-ploy offices /li liInsurance Benefits /li liFishing for Friends program – our referral program /li liFurther development and professional advancement /li liFriendly and international working environment /li liCompetitive salary and various benefits /li /ulpbrIs strongIT /strongin your DNA? /ppIf you believe you are a good match for this role, or any other opportunities for which D-ploy is currently staffing, then we are very keen to speak with you. You can apply though a variety of channels, including our website or by reaching out directly to our recruitment team. /p