Job position: CSV consultant
A job in computer validation requires technical analysis, document writing, execution of tests on software or automated systems, as well as a lot of interaction with different departments in the company where you work.
As CSV consultant you execute computer validation projects on location at a pharmaceutical company or from our offices. You are involved with the analysis of user requirements, testing and implementation of new software solutions.
For this position we are looking at all levels of experience, from starter to senior level.
Your responsibilities as CSV consultant include:
- develop a validation strategy which is realistic and meets current regulatory and client expectations, write validation plan and report
- write URS
- write IQ, OQ and PQ protocol (or other relevant test documents)
- plan and execute or oversee execution of computer validation tests
- manage quality records such as deviations, CAPA's and change controls
- participate to risk assessments and quality investigations
- ensure compliance to regulatory requirements such as 21CFR Part 11 or Eudralex annex 11, taking into account current trends and future vision of the client
- take decisions which properly balance out quality / budget / planning and help project stakeholders to reach a compromise on critical quality decisions
- fluent in English, at least conversational level in Dutch
- strong analytical skills, well organized, studious and precise
- affinity with ICT
- you enjoy managing documentation: creating documents, reviewing and updating, getting approval on documents
- commercial attitude, able to convince clients by communicating in a clear and enthusiastic way
- master degree in science, information technology or engineering, or equivalent through experience
Nice to have
- experience working in a pharmaceutical GxP environment
- experience in CSV
- experience in computer validation related roles such as tester or technical writer
- knowledge of Part 11, EU annex 11 or GAMP