Consultant m/w/d für CSV, CSA und Prozesse
Core
Plan, execute, and evaluate process and software tool validations in a GxP environment for medical device and pharmaceutical clients.
Role type
Senior IC Validation Consultant (CSV/CSA)
Builds
Validated processes and software tools for regulated medical devices and pharmaceutical products
Domain
MedTech / Pharma / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
CSV/CSA validation, GxP regulations, software development lifecycle, embedded systems, test automation, C/C++/Python, IEC 13485, ISO 14971, GAMP
Preferred skills
Hardware-software integration, test specification creation
Technologies
C, C++, Python, GAMP tools
Responsibilities
Plan and conduct process and tool validations, analyze requirements across the product lifecycle, build and operate test environments, clarify deviations, engage stakeholders
Seniority
Senior, hands-on IC
