Qualification & Validation Engineer Pharma
Must-have:QA/Test
Machine translation — original language: Dutch.Show original
Job Description
Do you want to help safeguard the quality of systems and processes within a pharmaceutical environment in Geel? For this assignment, we are looking for a Qualification Engineer to support the engineering team in the qualification of equipment and systems throughout their entire lifecycle.
Responsibilities
- You review and approve qualification and validation documentation, such as SOPs, URS, risk analyses, test plans, test scripts, change controls and CAPAs.
- You support engineering teams in the implementation of new or modified systems and processes.
- You advise on cGMP aspects and compliance during qualification and validation activities.
- You follow up on deviations and coordinate progress with QA teams.
- You hold a professional bachelor's or master's degree in a scientific or technical field, such as industrial sciences or bioengineering.
- You have demonstrable experience with qualification or validation activities within the pharmaceutical sector.
- You are familiar with GMP, GDP and safety documentation.
- Experience with change control management, preferably in TrackWise, is a plus.
- You communicate fluently, both orally and in writing, in English.