Deine Aufgaben Planung und Durchführung von Qualifizierungen (IQ, OQ, PQ) für Produktionsanlagen... in der Qualifizierung von Produktionsanlagen im GMP-Umfeld Fundierte Kenntnisse in IQ/OQ/PQ sowie in der Dokumentation gemäß...
activities (IQ/OQ/PQ) within a GMP environment. Resolve complex process or equipment issues by leading root cause investigations... and German Experience with GMP manufacturing unit operations Proven experience with equipment qualification (IQ/OQ/PQ...
21 CFR 211, and risk‑based validation concepts. Proficient in writing IQ/OQ/PQ protocols, reports, and deviation...
&D and program teams. Lead process validations (IQ/OQ/PQ), data analysis, and technical decision-making. Drive PPAP deliverables...
To Have: Experience with qualification activities (IQ, OQ, PQ) and related documentation experience or knowledge in 3D printing...
To Have: Experience with qualification activities (IQ, OQ, PQ) and related documentation experience or knowledge in 3D printing...
, and PQ protocols. Support qualification of process equipment, laboratory systems, HVAC systems, clean utilities, cleanrooms.... Strong understanding of GMP regulations and validation lifecycle methodologies. Hands-on experience with IQ/OQ/PQ execution, validation...
(Ofgem, BEIS, EU equivalents) and adjust GTM approach accordingly. Feed market insights into product roadmap (e.g., PQ...
und Produktionsprozessen im GMP-Umfeld Mitarbeit bei Qualifizierungs- und Validierungsaktivitäten (z. B. PQ, Reinigungs...
(z. B. PQ, Reinigungs- und Prozessvalidierung) Aufbau und Implementierung eines Schulungs- und Trainingssystems...