QA Officer Clinical
il y a 11 heures
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 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
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
- 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
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