Please apply if you are interested to work in contract mode
CSV: process is to design, build, test, release
Deep Understanding of the process is required
The consultant will receive Request for current application and apply knowledge to understand if GxP application is required or not
Role:
- Support GxP
- Risk Assessment
- Be part of Project charters - texting, training, approval of final reviews
- Ensure Project is compliant and good to go
Requester domains: Science, procurement, digital, pharmacovigilance, serialization, medical
Step By Step process to follow:
- Set of questions to business (gxp/non gxp)
- Project Initiation (project charter, workshops - whether process design is compliant- check for red flags)
- Documents- for approval (comments to revert back)
- Discuss testing outcome (in case of failures) - decision making
- Project golive
- Business tackles hypercare
- Hypercare deviation - involvement required
More involvement - initiation to handover for Quality projects - acting as business system owner /Business Quality representative
LIMS project (Validation, not front end) - continuous governance