Qualification Expert (Computer-based Lab Systems, Pharma)

D-ploy is an IT and Engineering Solutions company operating in EMEA. Join us for a dynamic work environment and great benefits!

Tasks

• Prepare computer-based system qualification deliverables in pharma.
• Review qualification documents generated by the project team.
• Support onsite lab IT in troubleshooting and configuration tasks., * 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

• Experience in big pharma, GxP, and document creation is essential.
• Excellent communication skills with clients and team members.
• Fluent in English and German, organized, and flexible., * 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

• Lunch 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)
• Enjoy free refreshments in our D-ploy offices
• Insurance Benefits
• Fishing for Friends program - our referral program
• Further development and professional advancement
• Friendly and international working environment
• Competitive salary and various benefits

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.