QA officer (GCP)

QA OFFICER (GCP)

MindCapture offers a dynamic and rewarding work environment. We have a strong focus on candidates and believe in long-term relationships that thrive on quality contacts and insight into career opportunities. Not only for our candidates, but also for our consultants, recruiters and support staff.

We offer strong compensation packages that reward your abilities, hard work and ingenuity in achieving success.

We reward you with competitive wages and offer a strong package with additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group insurance. Depending on your seniority, a car may be provided.

We provide personalized training to let you grow in the area of

• What you like to do
• What you are good at
• Where and how you want to have an impact

MindCapture collabs with a innovative clinical research center. It is a unique vaccine research centre where vaccines for all kinds of pathogens will be tested. This can further accelerate the fight against new and existing diseases. It houses a 30 bed quarantine unit and extensive BSL-2 and BSL-3 lab facilities as well as a large ambulatory trial unit (for phase 1, 2 and 3 trials). In the quarantine/contained unit, it will be possible to carry out Controlled Human Infections Model studies BSL-2 and BSL-3 pathogens (“challenge agents”).

We are looking for a QA Officer to help support the development of the quality system for conducting clinical trials and associated lab analyses (biosafety levels 2 & 3).

• Drafting quality documents and managing/updating them in the digital quality system at the request of the Head of QA
• Contributing to continuous improvement of the quality system
• Following up on staff training needs
• Preparation of reports for deviations, complaints and non-conformities
• Follow up on CAPAs
• Maintaining QA records at the request of Head of QA
• Involved in validation and qualification activities of (lab) equipment and processes
• Preparing data and reports related to quality (audits, inspections, meetings)
• Co-performing (internal) audits
• Preparation of data and organisation of supplier reviews
• Co-preparing the annual management review & the internal audit plan
• Reporting any difficulty or deviation identified to Head of QA
• Co-development of improvement projects

• University degree (or equivalent through demonstrable experience)
• At least 3 years’ experience in a relevant environment (preferably in clinical trials or in and industrial setting).
• You have experience with quality systems such as ISO/GMP/GCP/GLP/GCLP.
• Analytical thinking skills
• Quality-oriented attitude
• Eager to work in a team and have good communication skills
• Excellent knowledge of Dutch and good knowledge of English
• Very good knowledge of MS Office