CSV Senior Compliance Advisor
Core
Ensures IT-managed GxP computerized systems and infrastructure are validated or qualified in line with corporate quality standards and regulatory requirements for healthcare products.
Role type
Senior IC CSV Compliance Advisor
Builds
Validated computerized systems and qualified IT infrastructure for medical device and pharmaceutical manufacturing
Domain
Healthcare / Medical Devices / Pharmaceutical Manufacturing / Computer System 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, testing execution, regulatory compliance monitoring
Preferred skills
Experience with EDMS, PLM, eQMS, complaint management systems, ERP systems, project management, stakeholder influence
Technologies
EDMS, PLM, eQMS, complaint management systems, ERP systems
Responsibilities
Evaluate proposed new computerized systems to assess GxP impact and provide guidance on risk-based validation; Oversee development of validation deliverables including Validation Plans, Test Protocols, Specifications, and Validation Reports; Manage formal testing of computerized systems including setup, documentation, approval, and reporting; Review proposed changes to validated systems to identify qualification requirements; Conduct Quality Reviews to evaluate processes and deliverables for compliance; Maintain up-to-date knowledge of evolving regulatory requirements and act as an information resource
Seniority
Senior, hands-on IC
