Quality Assurance Engineer

Location Leiden
Discipline: Pharmaceutical
Contact name: Sayf Idais

Contact email: s.idais@panda-int.com
Job ref: 12309
Published: 22 days ago

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.

 

Responsibilities:

  • 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.

 

Required:

  • 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

Project duration:

6 months + possible extension / perm

Interested?

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 s.idais@panda-int.com