EXTEDO is the key software and service solutions provider in the field of Regulatory Information Management (RIM). We offer configurable off-the-shelf products as well as customized and integrated solutions. EXTEDO's enabling technology, the EXTEDOsuite, is unique in all that it covers within Regulatory Affairs including: eCTD submission management, pharmacovigilance or drug safety management and product registration planning & tracking. EXTEDO serves over 700 Life Sciences customers, both large and small, in 60 countries, including the EMA and over 25 regulatory authorities worldwide. The areas of Life Sciences in which Extedo operates are: pharmaceuticals, biotech and biopharma, generics, medical devices, healthcare and the public sector. We are still growing!

For our location in Ottobrunn near Munich we are actively seeking a

 

Validation Expert (m/f)

Your Tasks - as important as our Software:

 
  • You will advice our clients and support during preparation, implementation and acceptance of validation projects,
  • implement and develop your high standards of quality,
  • support the team to successfully implement business critical processes in compliance to strict requirements,
  • verify automated business processes,
  • track and control identified deficiencies within the validation process and support to implement and finally approve the validated environment,
  • get the chance to develop further within the organization in according to your strengths!

Your Profile - as good as our Solutions:

 
  • You have a degree or diploma in a technical or computer science discipline or a comparable qualification,
  • have an accurate and meticulous working method,
  • have expertise and skills to perform verification tasks based on acceptance criteria,
  • would like to ensure traceability of validation projects using documented evidence for clients from the regulated industry.
With your passion and professional knowledge you can help us implementing automated procedures with business critical applications for our clients in the pharmaceutical industry. With your high awareness of quality, process knowledge and skills you support the validation of GxP systems following GAMP 5 standard in compliance to common regulations e.g. US FDA 21 CFR Part 11 and EU GMP Annex 11. We offer development opportunities for experts in the field of quality management, quality assurance or software testing. This is your chance to put your standards of quality into practice.