D-ploy is an IT and Engineering Solutions company with operations 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 customers' IT productivity and contribute to their organization's success and value.
Key Responsibilities
* Prepare and execute 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 qualification deliverables generated by project team members.
* Migrate 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 delivery and project management processes required to complete projects within timeline and budget.
* Serve as Subject Matter Expert for qualification purposes and Point of Contact for regulatory inspections and audits.
* Support and deputize colleagues onsite.
Audit Support
* Assist in preparing audits to ensure organized collection of necessary documentation.
* Provide on-site support during audits to facilitate communication between teams.
* Manage significant amounts of documentation to ensure accuracy.
* Create qualification documents in accordance with audit standards.
* Create presentations to effectively communicate audit findings.
* Learn client's IT systems and update audit support best practices.
* Serve as key point of contact for communication between departments during audits.
* Demonstrate strong interpersonal skills and proactive problem-solving behavior.
Requirements
* Prior experience in similar roles.
* Excellent communication skills with clients, 3rd parties, project managers, 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 license for travel between client sites in Switzerland.
* Fluent in German and English, French is a plus.
* Candidates must provide a 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.
Are you passionate about IT?