Qualification Expert (Computer-based Lab Systems, Pharma) job opportunity at D‑ploy AG.

Home Jobs In Switzerland Tag: Pharma) Qualification Expert (Computer-based Lab Systems, Pharma) position at D‑ploy AG


Date2024-05-22T11:41:33.000Z bot
D‑ploy AG Qualification Expert (Computer-based Lab Systems, Pharma)
Experience: General
Pattern: Full-time
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Pharma)

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degreeGeneral
loacation Basel, Switzerland
loacation Basel....Switzerland

D-ploy is an IT and Engineering Solutions company with operations throughout the EMEA region including Switzerland, Germany, Czech Republic, Austria, UK, as well as the USA. We pride ourselves on delivering innovative and superior services and solutions to numerous industry-leading clients. By building relationships and trusted partnerships within the IT community, we optimize our customer‘s IT productivity and contribute to the organization’s success and value. We 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 IT counts, join us! Tasks and Responsibilities Preparation 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) Review of qualification deliverables generated by project team members Migration of computer-based lab equipment systems (Operating System, Data etc.) Provide help to onsite lab IT supporter in troubleshooting or system configuration specific topics Assist the Service Coordinator and Service Delivery Manager in the delivery and project management processes required to complete projects within timeline and budget Subject Matter Expert for qualification purposes and Point Of Contact for regulatory inspections and audits Support and deputize colleagues onsite Big pharma experience, document creation experience, GxP, and IO OQ PQ basic experience Working knowledge of qualification processes and Computer System Validation concepts Good 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) Lab environment, ITIL and IT knowledge is an advantage Excellent communication skills with client, 3rd party, project manager and team members Proven ability to prioritize and manage multiple demands, projects and cross-functional teams Experienced in technical communication, which includes but is not limited to technical writing, instructional design, technical editing, copy, editing or proofreading and quality assurance Good at gathering feedback and implementing improvements Self-responsible, self-organized and flexible person Multi-tasking and handling changes in requirements or schedule Willingness to work at different customer locations Fluent in English and German (spoken & written) Candidates must provide Criminal record extract not older than three months

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