Mitarbeiter*in QA-Oversight Qualifizierung, Wartung, Kalibrierung, und DataIntegrity
Core
Ensuring compliance with GxP regulations for equipment, room, and computer system qualifications, calibrations, and maintenance through QA oversight and document approval.
Role type
QA Oversight Specialist (GxP)
Builds
GxP-compliant qualification, calibration, and maintenance processes for pharmaceutical production and quality control.
Domain
Pharmaceutical industry / GxP compliance
Required skills
GMP requirements knowledge, equipment qualification processes, risk assessment, technical process understanding, database systems (SAP), MS Office, German, English
Preferred skills
None stated
Technologies
SAP, MS Office
Responsibilities
Conduct QA oversight of GxP-relevant qualifications, calibrations, and maintenance; approve GxP documents; support risk assessment and risk analysis; develop QA oversight concepts; represent tasks in audits and inspections; ensure data integrity of computer-based systems.
Seniority
Mid-level, hands-on specialist
