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 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
Must have
- Fluent in English, at least conversational level in Dutch.
- Affinity with ICT.
- Strong analytical skills, well organized, studious and precise.
- You enjoy managing documentation: creating documents, reviewing and updating, getting approval on documents.
- Commercial, able to convince clients by communicating in a clear, enthusiastic way.
- Master degree in science or engineering, or equivalent through experience.
Nice to have
- Experience working in a 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.
What is great about this job?
- As a consultant, you will find yourself working with exciting companies in the Life Sciences sector.
- You will use your knowledge and skills to tackle challenges faced by our clients.
- A consultancy job can be a calling, or a springboard to the start of a career as a technical expert, people manager, or multipotential.
- Trevalco is not a multinational with thousands of employees, but a Belgian SME, so you are not just a number with us.
What we do
What we offer
As an employer, we contribute to the success of your career. Proper guidance and training are very important to us. Naturally, we also ensure that you feel good in your job through a healthy work/life balance, a market-competitive salary, and tailored solutions for aspects such as mobility.
Salary
CAO90 bonus, hospitalisation and dental care insurance, meal vouchers and more
Mobility
you choose what works best: company car or mobility budget
Training
coaching, classroom or digital online training, what works for you
Work / life
because we have families, friends and hobbies
