Role & Responsibilities

Conception, planning and performing of Computer Systems Validation (CSV) in the regulated environment (Pharma, Medical Devices, Biotech)

Advisory and support of application owners to build and maintain GxP conform systems

Support and consulting during projects handling GxP critical computer systems

Implementation of qualification / validation activities within projects of new and existing computer systems according to our client requirements

Conception and implementation of Raw-Data-Handling systems and solutions (Data Integrity)

Computer systems according to internal Software Development Lifecycle

Performing internal and external CSV trainings

Position Requirements

University degree in Informatics, Quality, Engineering or another relevant discipline

At least 2-3 years of experience in validation of GxP relevant IT systems such as ERP, MES, LIMS or Quality Systems

Working knowledge of national and international regulations and standards, eg. GAMP5, ISO 9001, ISO 13485, ISO 62304, FDA QSR, 21 CFR Part 820, Part 11

Analytical and structured working style; strong attention to detail

Ability to effectively work as part of a multidisciplinary, international team

Hands-on personality, with flexibility and dedication to maximize our client s value

Good verbal and written communication skills in English, German language is a plus