About D-ploy
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.
Our team consists of engaging, flexible, and solution-oriented individuals who are dedicated to creating value where IT counts.
Job Description
As a key member of our team, you will be responsible for preparing and executing computer-based system qualification deliverables in a pharmaceutical environment. This includes:
* Project planning and execution (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
* Migrating computer-based lab equipment systems (Operating System, Data etc.)
* Providing help to onsite lab IT supporters in troubleshooting or system configuration specific topics
* Assisting the Service Coordinator and Service Delivery Manager in delivery and project management processes
* Serving as a Subject Matter Expert for qualification purposes and Point Of Contact for regulatory inspections and audits
* Supporting and deputizing colleagues onsite
Responsibilities
1. Preparation and execution of computer-based system qualification deliverables in a pharmaceutical environment
2. Review of qualification deliverables generated by project team members
3. Migrating computer-based lab equipment systems
4. Providing help to onsite lab IT supporters
5. Assisting the Service Coordinator and Service Delivery Manager
6. Serving as a Subject Matter Expert for qualification purposes
7. Supporting and deputizing 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 a 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