Qualification & CSV Specialist | Freelancer
Core
Execute equipment, facility, and system qualification and computerized system validation (CSV) activities for pharmaceutical, biotech, and medical device projects.
Role type
Freelancer Qualification & Validation & CSV Specialist
Builds
Validated equipment, facilities, and computerized systems for pharma/biotech clients
Domain
Pharmaceutical, Biotechnology, Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Equipment qualification, Validation protocols (DQ/IQ/OQ/PQ), CSV (GAMP 5), Validation documentation (URS, Risk Assessments, Plans, Scripts, Reports), Change Controls, CAPAs, GxP/GMP, GAMP 5, Annex 11
Preferred skills
Technical rigor, Analytical problem-solving, Organization, Client orientation
Technologies
GAMP 5, GMP, GxP, Annex 11
Responsibilities
Execute qualification of equipment, facilities, utilities, and systems; Develop and execute validation protocols; Prepare technical validation documentation; Support Change Controls, CAPAs, and investigations; Collaborate with multidisciplinary teams and clients
Seniority
Mid-level, hands-on IC
