Qualification Expert

Vor 7 Tagen

Basel, Basel-Stadt, Schweiz D-ploy Vollzeit

D-ploy is a leading IT and Engineering Solutions company with a strong presence in the EMEA region and the USA. We pride ourselves on delivering innovative and superior services and solutions to industry-leading clients.

As a Qualification Expert, you will be responsible for preparing and executing computer-based system qualification deliverables, including project plans, HLRA, URS, QPlan, IQ, OQ, PQ, ERES assessment and Verification, Q-Report, risk assessment, decommissioning test plan, and SOP. You will also review qualification deliverables generated by project team members and provide help to onsite lab IT supporters in troubleshooting or system configuration specific topics.

Key Responsibilities:

  • Preparation and execution of computer-based system qualification deliverables
  • Review of qualification deliverables generated by project team members
  • Migration of computer-based lab equipment systems
  • Providing help to onsite lab IT supporters
  • Assisting the Service Coordinator and Service Delivery Manager in the delivery and project management processes
  • Subject Matter Expert for qualification purposes and Point Of Contact for regulatory inspections and audits
  • Supporting and deputizing colleagues onsite

Requirements:

  • Big pharma experience and document creation experience
  • Working knowledge of qualification processes and Computer System Validation concepts
  • Good understanding of and motivation for working in regulated environments
  • Lab environment, ITIL, and IT knowledge is an advantage
  • Excellent communication skills
  • Proven ability to prioritize and manage multiple demands, projects, and cross-functional teams
  • Experienced in technical communication
  • 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

Benefits:

  • Broad range of activities, tasks, and projects
  • Lunch Checks or Reka Money
  • Enjoy free refreshments in our D-ploy offices
  • Insurance Benefits
  • Fishing for Friends program
  • Further development and professional advancement
  • Friendly and international working environment
  • Competitive salary and various benefits

Is IT in your DNA?

If you believe you are a good match for this role, we are keen to speak with you. You can apply through our website or by reaching out directly to our recruitment team.

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