For one of the biggest leading Pharma company. We are looking for a highly skilled Quality Assurance Engineer. You will be working in a multidisciplinary and international team on a broad range of activities, from Quality Management System activities to risk management and process validation. The project might require you to travel between Groningen and Noord-Brabant on an incidental basis. It is possible to work remotely but depending on the phase of the project less or more days on site are required. The position is a 6-month contract with option to extend or a contract at the client. The job is based in Groningen.
- Lead risk management activities (FMEA).
- Support process validation process (IQ/OQ/PQ/Test Method Validation) via proactive support, and review and approval of documentation.
- Support commercial manufacturing readiness.
- Review and approve project documentation.
- Ensure that the change control procedures are correctly applied.
- Oversee QMS activities per existing plan and support execution.
- You have a good working knowledge of the applicable regulations regarding the development and production of medical devices, in line with the Medical Devices Regulation, 21CFR Part 820, ISO 13485 and ISO 14971.
- At least 5 years of relevant work experience preferably in the pharmaceutical or medical device industry
- A relevant Bachelor or Master of Science degree (technical, life science or related);
- Preferably working knowledge of validation of Automated / Computerized Systems and its validation
- Working knowledge of equipment qualification, process validation, risk management, change control.
- Good communicative skills, excellent command of the English language and preferably the Dutch language.
Project start date:
Short notice preferred
6 months + possible extension / perm
If you are interested in the above description, please apply with your CV and a letter of motivation.
PS: Did you also know that we offer a generous referral scheme, because great people know other great people, right?
For further information, please contact Sayf Idais at +31 (0)20 20 44 502 or by email at firstname.lastname@example.org