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Quality Management Specialist (contractor) - Mechelen, BE
Shared Services - Quality & Compliance
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Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company. We’re in the business of changing lives.
Galapagos’ mission is to make a lasting positive contribution to society through discovery of innovative therapies for diseases with large unmet medical need. Galapagos’ historic focus on developing first-in-class medicines based on the discovery of novel targets in inflammation and fibrosis has led to the successful launch of our first medicine in rheumatoid arthritis in 2020 and in ulcerative colitis in 2021. The pivotal study in Crohn’s Disease is fully recruited and we expect topline data and potential approval in this new indication in a couple of years.
Galapagos is now entering an exciting new chapter to expand and diversify its pipeline for the future, starting with oncology, specifically CAR-T cell-therapy, a transformative treatment of different types of cancer. Through the combined acquisitions of CellPoint and AboundBio, we are propelling ourselves into next-generation cell therapies.
Scope of the project
You will be responsible for the operational management of the Quality Management System (QMS) module hosting the audits and associated quality records, as well as for the operational management of quality processes in the QMS as CAPA and effectiveness check.
- Compilation of data for the update of the Master Audit Plan (MAP) and upload in the QMS system
- Creation of audit / qualifications records in QMS
- Upload of final audit reports in QMS (from external auditors)
- Creation of finding records in QMS
- Preparation of CAPA response template
- Upload of CAPA plan in QMS
- Follow-up of CAPA and evidence
- Participation in the preparation of inspection
- Follow-up of the request for new vendors qualification
Who are you?
- Bachelor or Master Degree in any field
- Minimum 2 years of Pharma QA experience required
- Accurate and precise with the ability to plan activities and organize own work to meet deadlines and strong organization skills
- A strong personality, high degree of flexibility, assertiveness and excellent communication skills
- System minded and has a good knowledge of current computer applications (Word, Excel, ...). In addition, well-developed problem solving, decision-making and analytical thinking skills
- Providing support is frequent and require excellent interpersonal skills and diplomacy
What’s in it for you?
You will be part of a fast growing and amazing company. You will get all the support you need to make your project successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our talented people are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research.
We are Galapagos: together we can make it happen…!