Qualification Expert

Vor 3 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 numerous industry-leading clients.

Our team is looking for a highly skilled Qualification Expert to join our ranks. As a key member of our team, you will be responsible for preparing and executing computer-based system qualification deliverables in a pharmaceutical environment.

Key responsibilities include:

  • Preparation and execution of qualification deliverables (project plan, HLRA, URS, QPlan, IQ, OQ, PQ, ERES assessment and Verification, Q-Report, risk assessment, decommissioning test plan, SOP)
  • 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

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

Are you a skilled professional looking for a new challenge? If so, we encourage you to apply for this exciting opportunity.

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