Quality Assurance (QA) Expert | Pharmazeut (m/w/d)

Job Summary

This role involves serving as a Quality Assurance Expert, providing quality-assuring support for construction and implementation projects within a highly regulated GMP environment, including cleanrooms, technical building equipment, production facilities, and associated software. Key responsibilities include planning, executing, and documenting all qualification activities (Design, Installation, Operational, and Performance Qualification - DQ, IQ, OQ, PQ) for systems and equipment. The expert is responsible for creating, reviewing, and approving quality-relevant documentation such as User Requirement Specifications (URS), risk analyses, validation plans, and Standard Operating Procedures (SOPs). A critical function is ensuring strict adherence to international regulatory requirements (EU-GMP, FDA, ICH, ISO) and supporting official authority inspections. The position requires close cross-functional collaboration with Engineering, Production, QC, and Validation teams to manage deviations, change controls, and CAPAs, contributing significantly to the continuous improvement of qualification processes within this innovative BioTech company specializing in cell and gene therapies.