GMP Document Manager (m/f/d)

ProBioGen is an internationally operating BioTech company based in Berlin-Weißensee, which specialises in the development and production of biopharmaceutical active and vaccines through years of experience. Over 270 employees contribute to the establishment of new therapeutic developments in medicine and pioneering innovations worldwide with their creative and careful work.

With our research we support the development of effective and safe medical active ingredients so that diseases such as cancer can be cured better.

Since 1994, we have been growing steadily – Become a driver of innovation*in the morning and get involved now!

Examination of raw data and compilation of production documentation for cell banks and active substances, including in-process controls (IPC) Creation, maintenance and verification of GMP-compliant documents (e.g. production documents, SOPs, logbooks) and master data maintenance in electronic systems Creation and testing of qualification and risk documents (e.g. for devices, procedures, projects) Processing and control of GMP compliance activities (e.g. deviations, CAPAs, Change Controls) Support in planning, preparation and implementation of employee training in production Support for production management in ensuring a GMP-compliant operation, including technical monitoring and regular inspections of storage and production areas

Complete studies in the field of biotechnology, bioprocess engineering or related natural sciences (e.g. biology, biochemistry, chemistry, pharmacy) or comparable training (BTA, MTA etc.) At least two years of professional experience in the GMP-regulated environment Experience in bioprocess engineering and safe handling of MS Office, electronic document management and other digital systems Very good knowledge of German and English in word and writing Impressed communication and organisational skills and rapid understanding Self-sponsored, responsive and flexible working methods as well as strong team skills

ProSphere. Partnership environment with ''Du' culture, corporate events ProBalance. Flexible work and special holiday days ProHealth. Yoga, Shiatsu, Health Days and Benefits in the Urban Sports Club ProCare. Technical equipment, laboratory clothing, screen glasses, occupational retirement Prokey. Cafeteria with Convini-Fridge, daily fresh lunch and free drinks ProTalent. Onboarding with sponsorship program, innovation days, training offers, coaching