Role -CSV Validation Specialist

Location -Hyderabad

Experience -8 to 15 Years

Notice Period -0 to 15 days

Contract for 1 Year

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 new 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 valuable 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

Jira, Confluence is good to have

📌 CSV Validation Specialist (Hyderabad)
🏢 Thompsons HR Consulting
📍 Hyderabad