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Junior Qualification and Audit Support Expert (with Lab IT experience), Stein Client: D-ploy
Location: Job Category: Other
Job Reference: 29da37f1a4de
Job Views: 4
Posted: 14.03.2025
Expiry Date: 28.04.2025
Job Description: 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
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
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