The CSV/CQV Consultant will provide hands-on support for CSV remediation across laboratory systems in an environment where processes are being developed in parallel with execution. Responsibilities include:
Perform CSV gap assessments on existing laboratory systems (e.g., HPLC, TLC, Environmental Monitoring)
Review historical validation documentation and system state
Conduct gap analyses and define remediation approaches
Collaborate with Quality, IT, and Lab stakeholders as processes mature
Potential spillover into CQV and equipment validation support as needed
Support multiple concurrent initiatives, including ongoing and new Veeva implementations
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