Junior Qualification and Audit Support Expert (with Lab IT experience)

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!

Responsibilities

Qualification:

• 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

Audit Support

• Assist in the preparation of audits to ensure organised collection of necessary documentation
• Provide on-site support during audits to facilitate communication between teams
• Managing a significant amount of documentation to ensure accuracy
• Creating qualification documents in accordance with audit standards
• Creating presentations to effectively communicate audit findings
• Learning the client's IT systems and updating audit support best practices
• Serve as a key point of contact for communication between departments during audits
• Demonstrate strong interpersonal skills and proactive problem solving behavior

Requirements:
• Previous experience in similar roles
• Excellent communication skills with client, 3rd party, project manager and team members
• Good at gathering feedback and implementing improvements
• Self-responsible, self-organized and flexible person
• Multi-tasking and handling changes in requirements or schedule
• Proactive and inquisitive mindset with a strong willingness to learn.
• Confident with documentation and creation of qualification documents.
• Ability to work independently and collaboratively.
• Willingness to work at different customer locations
• Valid driving licence for travel between client sites in Switzerland.
• Fluent in German and English, French is nice to have
• Candidates must provide Criminal record extract not older than three months

Nice to have:

• Lab, ITIL, and IT knowledge environment
• Big pharma experience, document creation experience, GxP, and IO OQ PQ basic experience
• 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)
• Experienced in technical communication, which includes but is not limited to technical writing, instructional design, technical editing, copy, editing or proofreading and quality assurance

Benefits:
• Wide range of activities, tasks and projects
• Lunch Checks or Reka Card (Lunch Checks can be used in over 7000 restaurants, Reka Card can be used for lunch, transport & accommodation, sports & well-being, leisure & culture, holidays & travel)
• Fishing for Friends programme - our referral programme
• Further development and career progression
• Friendly and international working environment

Is IT in your DNA?