Job position: validation consultant
A job as validation consultant in the pharmaceutical industry has a lot of variation. It includes technical analysis, document writing, execution of tests in production or laboratory environments, as well as a lot of interaction with different departments in the company where you work.
As validation consultant you execute validation projects on location at clients in the pharmaceutical industry. This can be production equipment validation, lab equipment validation but it can also concern the validation of facilities and utilities, processes and computer systems. Depending on your background and interests you will be active in one or more of these areas.
For this position we are looking at all levels of experience, from starter to senior level.
Your responsibilities as validation 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
- plan and execute or oversee execution of qualification tests
- manage quality records such as deviations, CAPA's and change controls
- participate to risk assessments and quality investigations
- participate to internal and external audits
- advise on pharmaceutical regulatory requirements such as GMP, GLP and GDP, 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
- you can explain, you can convince, you can correct... you have perfect communication skills
- you enjoy managing documentation: creating documents, reviewing and updating, getting approval on documents
- master degree in science or engineering, or equivalent through experience
Nice to have
- experience working in a GxP environment
- experience as tester or technical writer
- knowledge of pharmaceutical regulations