Job Zusammenfassung
Du entwickelst und führst Qualifizierungs- und Validierungspläne durch. Dabei erstellst und prüfst Du Protokolle und Berichte, um die Einhaltung von Vorschriften sicherzustellen.
Über den Job:
Argo-X
Argo‑X is a specialist consultancy that delivers flexible, high‑impact staffing to pharma, biotech, medical‑device and diagnostics companies worldwide. Our consultants operate in GxP environments, helping clients accelerate product development while staying fully compliant with evolving regulations.
TASKS
Develop and execute qualification and validation plans for instruments, utilities, and production lines.
- Author and review protocols, test scripts, and final reports ensuring traceability and compliance.
- Perform risk assessments, define acceptance criteria, and manage change control.
- Support auditors during inspections and provide evidence of validated state.
- Mentor client staff on best practices and maintain validation documentation libraries.
REQUIREMENTS
BSc/MSc in Engineering, Chemistry, Biotechnology or related field.
- Minimum 4 years of hands‑on CQV experience in GMP‑regulated environments.
- Strong familiarity with EU Annex 15, FDA 21 CFR 211, and risk‑based validation concepts.
- Proficient in writing IQ/OQ/PQ protocols, reports, and deviation investigations.
- Ability to travel to client sites (Europe) and work under tight timelines.
Join Us! Why Argo‑X?
Join a network where your expertise is matched to high‑visibility projects that shape the future of healthcare. Enjoy flexible assignments, competitive rates, and continuous professional development.
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Job-ID.: 28925976
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