Qualifizierungsspezialist (x|w|m)
Core
Support the creation, maintenance, and review of production and quality-relevant documentation, specifically test documents for Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), and re-tests.
Role type
Qualification Specialist (Quality Assurance)
Builds
FAT, SAT, and re-test documentation and processes
Domain
Life Sciences / Bioprocessing Systems
Deliverable
dashboards & analysis
Required skills
Technical understanding, Microsoft Excel, structured and careful work style, problem-solving competence, analytical thinking, high quality awareness
Preferred skills
Experience with documentation and process requirements in a regulated environment, Good English skills, fluent German skills
Technologies
Microsoft Excel
Responsibilities
Support the preparation and documentation of qualification activities including test references, Quality Test Record (QTR), Validation Master Plan (VPR), and report finalization; Conduct internal training on test documents and Good Documentation Practice; Process internal quality notifications.
