Qualification Expert
vor 4 Wochen
D-ploy is a leading IT and Engineering Solutions company with a strong presence in the EMEA region and the USA. We pride ourselves on delivering innovative and superior services and solutions to numerous industry-leading clients.
Our team is focused on creating value where IT counts, and we are seeking a highly skilled and experienced individual to join our team as a Qualification Expert in a pharmaceutical environment.
The successful candidate will be responsible for preparing and executing computer-based system qualification deliverables, including project plans, HLRA, URS, QPlan, IQ, OQ, PQ, ERES assessment and Verification, Q-Report, risk assessment, decommissioning test plan, and SOP.
Key responsibilities will include reviewing qualification deliverables generated by project team members, migrating computer-based lab equipment systems, and providing help to onsite lab IT supporters in troubleshooting or system configuration specific topics.
The ideal candidate will have big pharma experience, document creation experience, GxP, and IO OQ PQ basic experience, as well as a working knowledge of qualification processes and Computer System Validation concepts.
Additional requirements include a good understanding of and motivation for working in regulated environments, lab environment, ITIL, and IT knowledge, excellent communication skills, and the ability to prioritize and manage multiple demands, projects, and cross-functional teams.
We offer a broad range of activities, tasks, and projects, lunch checks or Reka Money, insurance benefits, and further development and professional advancement opportunities.
If you are a highly skilled and experienced individual looking for a new challenge, we encourage you to apply for this exciting opportunity to join our team at D-ploy.
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