MX/ LS CSV Consultant - Business Consulting
Core
Consultant specializing in IT Computerized System Validation (CSV) for Life Sciences, ensuring compliance in system development and release cycles.
Role type
Senior IC business consultant (CSV)
Builds
Validated IT systems and compliance deliverables for Life Sciences clients
Domain
Life Sciences / Pharmaceutical Compliance
Required skills
IT Computerized System Validation (CSV), 21 CFR Part 11, GxP, GAMP 5, Risk Management, Agile methodologies, Project Management, Compliance Auditing
Preferred skills
IT background, ServiceNow, JIRA, Veeva, HPALM
Technologies
ServiceNow, JIRA, Veeva, HPALM, Agile, Waterfall
Responsibilities
Create, review, and approve validation deliverables; Define IT system development processes following Agile; Author major project validation deliverables; Review and approve system lifecycle deliverables; Guide project teams on validation and security deliverables; Contribute to internal and external audits; Escalate critical compliance findings; Prepare management reports regarding compliance operations
Seniority
Consultant level, hands-on IC