IT Specialist for Qualification and Validation in Pharmaceutical Production (m/f/d)

Ensuring location-related IT compliance for production facilities, such as user management, patch management, cyber security, data storage Administration and support of computer-assisted systems including account management and system monitoring Validation of computer-assisted systems including the creation of GMP-relevant documents as well as evaluation of technical changes and new installations with regard to GMP conformity Planning, implementation and documentation of qualifications (DQ, IQ, OQ, PQ) for production plants and technical systems Control and coordination of internal departments and external service providers in qualification and IT projects Support for deviations, disturbances and change control processes, including risk analyses (e.g. FMEA) and CAPA measures Professional representation in audits and inspections as well as preparation, monitoring and refurbishment of regulatory and customer-related audits

Complete study of engineering, pharmaceutical or medical technology, biotechnology or comparable qualification Multiannual professional experience in the GMP-regulated environment Knowledge of plant qualification or computer-assisted systems Understanding IT processes in the production environment, such as networks, user roles and data security Safe handling of technical documentation and communication Very good German (min. B2) and English knowledge in word and writing Communication strength, organisational skills and team skills High reliability and an independent, careful and conscientious procedure

Flexibility: design of working hours through flexible working hours and decentralised paid allowances (e.g. moving or dates for cancer prevention) for an optimal work-life balance Family-friendliness: support in the reconciliation of family and profession, through paid allowances for family events, such as child-hospitable days, family start time or your own wedding Work comfort: pleasant working environment without large-scale office and shiftwork, as well as ergonomic tables and chairs for comfort at work Compensation package: Attractive remuneration as well as asset-effective services and property vouchers or JobTicket Holiday and recreation time: 30 days holiday for regular rest and to recharge energy Stability & Perspective: Safe workplace in an established company with long-term prospects and development opportunities Health promotion: occupational health management with CampusVital Card, health days and actions like ''Fit and active in the day'' - the health of our employees is at our heart Variety of mobility: JobTicket, e-bike leasing, a good ÖPNV connection as well as company-owned charging stations for e-cars and the possibility of free charging of e-bike batteries for sustainable mobility