Validierungs-Spezialist (m/w/d) CSV
Core
Lead CSV projects for IT system validation and qualification processes in the pharmaceutical industry, creating documentation and conducting tests.
Role type
Validation Specialist (CSV)
Builds
Qualification and validation documentation, protocols, reports, and GMP documents for pharmaceutical clients.
Domain
Pharmaceutical industry / IT System Validation / GMP Compliance
Deliverable
client delivery
Required skills
GMP requirements knowledge, EU-GMP guidelines (Annexes 11 & 15), GAMP 5, MS Office, risk analysis, project leadership, client consultation
Preferred skills
English (fluent), German (C1+), analytical approach, negotiation skills, travel readiness
Technologies
MS Office, GAMP 5
Responsibilities
Create qualification and validation documents including protocols and final reports, conduct FAT/SAT and qualification activities, perform and document alarm and function tests, create and execute general GMP documents like SOPs and concepts, document and moderate risk analyses, guide assigned personnel at client projects, present projects internally and externally, support acquisition and budget management, consult clients on CSV topics
Seniority
Mid-level, hands-on IC