CareerPlan

Qualifizierungsexpert*in (alle Geschlechter)

Leverkusen,North Rhine Westfalia,GermanyFull-time€54k2026-10-14 → 2026-11-06

Core

Develop and execute qualification strategies and GMP-compliant documentation for production and HVAC (TGA) facilities and rooms to ensure regulatory compliance.

Role type

Senior GMP Qualification Specialist

Builds

Qualification plans, risk assessments, and audit-ready documentation for pharmaceutical manufacturing facilities

Domain

Pharmaceutical manufacturing / GMP compliance

Required skills

GMP qualification, GMP documentation, risk assessment, IQ/OQ/PQ planning, facility qualification, MS Office, ValGenesis, IQMS, SAP

Preferred skills

Master qualification, solid particle production experience, interdisciplinary collaboration

Technologies

ValGenesis, IQMS, SAP

Responsibilities

Create GMP documents for qualifications and periodic reviews, plan and coordinate qualification tests, execute and document tests, optimize qualification strategies, manage quality documents

Seniority

Senior, hands-on IC