QA Officer Clinical - Antwerpen, België - MindCapture

MindCapture

Geverifieerd bedrijf

Antwerpen, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

QA OFFICER CLINICAL

Clinical
AntwerpWHAT IS OFFERED

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

ABOUT THE COMPANY
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 nonconformities
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)
Coperforming (internal) audits
Preparation of data and organisation of supplier reviews
Copreparing the annual management review & the internal audit plan
Reporting any difficulty or deviation identified to Head of QA
Codevelopment of improvement projects

REQUIRED COMPETENCES & SKILLS

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
Qualityoriented 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