Qualification Specialist

Vor 5 Tagen


Basel, Basel-Stadt, Schweiz D-ploy Vollzeit
Key Responsibilities

As a Qualification Expert at D-ploy, you will be responsible for the preparation and execution of computer-based system qualification deliverables, including project plans, HLRA, URS, QPlan, IQ, OQ, PQ, ERES assessment and Verification, Q-Report, risk assessment, and decommissioning test plan.

Key tasks include reviewing qualification deliverables generated by project team members, migrating computer-based lab equipment systems, providing support to onsite lab IT supporters, and assisting the Service Coordinator and Service Delivery Manager in delivering projects within timeline and budget.

Requirements
  • 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

Benefits

  • Broad range of activities, tasks, and projects
  • 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

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