About D-ploy
D-ploy is an IT and Engineering Solutions company with a strong presence throughout the EMEA region, including Switzerland, Germany, Czech Republic, Austria, UK, and 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.
Job Role
We are seeking a highly motivated and solution-oriented Junior Qualification and Audit Support Expert with lab IT experience to join our team in Stein.
The ideal candidate will be responsible for supporting our clients in the preparation of qualification deliverables, managing documentation, and providing on-site support during audits.
Key Responsibilities
* Preparation and execution of computer-based system qualification deliverables, including project plans, risk assessments, and verification reports.
* Review of qualification deliverables generated by project team members.
* Migration of computer-based lab equipment systems, including operating system upgrades and data transfers.
* Providing help to onsite lab IT supporters in troubleshooting and system configuration topics.
* Assisting the Service Coordinator and Service Delivery Manager in the delivery and project management processes required to complete projects within timeline and budget.
* Serving as Subject Matter Expert for qualification purposes and Point of Contact for regulatory inspections and audits.
Audit Support
* Assisting in the preparation of audits to ensure organized collection of necessary documentation.
* Providing on-site support during audits to facilitate communication between teams.
* Creating presentations to effectively communicate audit findings.
Requirements
* Previous experience in similar roles, preferably in a pharmaceutical environment.
* Excellent communication skills with clients, third-party vendors, project managers, and team members.
* Good at gathering feedback and implementing improvements.
* Self-responsible, self-organized, and flexible individual who can multi-task and handle changes in requirements or schedule.
* Proactive and inquisitive mindset with a strong willingness to learn.
* Confident in creating and maintaining documentation, including qualification documents.
* Ability to work independently and collaboratively.
* Valid driving license for travel between client sites in Switzerland.
* Fluent in German and English, French is a plus.
Nice to Have
* Lab, ITIL, and IT knowledge environments.
* 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 regulated environments, including GxP methodologies, 21 CFR Part 11 compliance, ALCOA+ principles, and latest industry expectations for Data Integrity.
What We Offer
* Lunch checks or Reka card for lunch, transport, and accommodation.
* Fishing for Friends referral program.
* Further development and career progression opportunities.
* Friendly and international working environment.