eCSV Senior Compliance Advisor
Core
Oversee GxP impacting projects to ensure regulatory compliance for new or revised computerized systems in pharmaceutical manufacturing, ensuring systems are fit for purpose and defendable during inspections.
Role type
Senior IC eCSV Compliance Advisor
Builds
Validated computerized systems supporting the development, manufacture, and distribution of medical products
Domain
Pharmaceutical manufacturing / Medical device industry / Computer Systems Validation (CSV)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP regulations knowledge, risk-based validation approach, validation documentation development, change control management, supplier assessment, quality review execution, PLC understanding, electronic systems experience
Preferred skills
Engineering background, experience with EDMS/PLM/QMS/LIMS/ERP systems, stakeholder influence, adaptability
Technologies
EDMS, PLM, QMS, LIMS, CMS, ERP, PLCs
Responsibilities
Evaluate proposed computerized systems for GxP impact and guide risk-based validation; oversee development of validation deliverables including plans, protocols, and reports; manage formal testing of computerized systems; review proposed changes to validated systems to identify qualification requirements; conduct quality reviews to evaluate processes and deliverables; maintain up-to-date knowledge of evolving regulatory requirements.
Seniority
Senior, hands-on IC
