CSV (Validation) Lead (GxP)

Q1 Technologies India PVT

Job Location:

Budapest - Hungary

Monthly Salary: Not Disclosed

Posted on: 9 days ago

Vacancies: 1 Vacancy

Job Summary

Define and drive CSV strategy standards and validation roadmap
Manage end-to-end validation lifecycle (IQ OQ PQ revalidation)
Ensure GxP compliance and regulatory adherence (FDA 21 CFR Part 11 Annex 11)
Oversee validation documentation and approvals (VP URS RTM reports)
Lead validation of GxP systems (ERP LIMS QMS MES)
Ensure data integrity security and audit readiness
Collaborate with QA IT business stakeholders and system owners
Manage CSV projects timelines risks and deliverables
Support audits inspections CAPA and compliance activities
Provide team leadership mentoring and vendor coordination