We are a service provider company offering services in the IT and non-IT areas as well as in the regulated and nonregulated environment We specialize in providing services in the pharmaceutical, chemical, medical, and IT System Engineering industries. Our headquarters is located in Switzerland and we have offices also in Germany and the USA the current number of employees is over 60.
Your main tasks:
• Support the local Laboratory Execution System and Quality Control Excellence teams in qualification activities
• Creating and executing IT-related qualification documents in a GxP-regulated environment (IQ/OQ)
• Carrying out compliance assessments (e.g. Electronic Records Electronic Signatures) regarding PC hardware and software
for laboratory systems in collaboration with the respective manufacturers
• Analysis of instrument software and creation of software installation qualifications
• Contact person for IT and compliance
• Support in the creation of standard operating procedures and work procedures
Your profile:
• Experience and/or knowledge in the pharmaceutical field
• Knowledge of the CSV area (GAMP 5, V-model, FDA 21 CFR Part 11, EU Annex 11)
• Experience and/or affinity in the IT sector.
• High willingness to learn
• Analytical thinking
• Willingness to work at the Marburg location
• Very good knowledge of German and English, both spoken and written
• Independent and responsible way of working
• Very good communication skills when dealing with customers
Your benefits:
• Family and international team
• Relaxed working atmosphere
• Flexible working hours
• Varied activities
• Project work
• Annual team events
• Fair salary + bonus payments