Junior CSV & Qualification Engineer

  • Consultys
  • Lausanne, VD, Switzerland
  • 20/09/2019
Full time Data Science Data Analytics Big Data Statistics

Job Description

In your role as a Consultys Compliance Expert, you are supporting our local clients and team by:

Roles and 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 exist- ing 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

Qualifications:

  • 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 structuGREAT 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

You can differentiate Consultys from the pack. Whether you are a graduate or an experienced professional, if you feel you would thrive in our environment, we would be pleased to hear from you.