QA Specialist - Mechelen,BE
Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville & Paris), the Netherlands (Leiden), Switzerland (Basel), Italy (Milano), Spain (Madrid), the UK (London), Germany (München), and in the US (Boston).
We are in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you.
We are looking for a QA Specialist - Mechelen, BE
Scope of the role:
You will mainly collaborate with the Quality Assurance Lead and will conduct the delegated QA lead activities, providing the necessary support in QA dedicated project.
- Coordinate the delegated audit activities as per current Master Audit Plan under supervision of QA lead
- Participate in the auditor selection and manage contractual agreements included related documents (e.g. review of proposals, initiating SoW creation)
- Support maintenance of qualified providers list
- Coordinate of delegated audit activities and CAPA formulation, follow up on CAPA implementation until audit closure
- Generates reports to follow up and to ensure oversight on audit activities and CAPAs status
- Process quality assessment in Audit Management System, managing contract agreements in case of external quality assessments and follow up on related CAPAs, when applicable
- Continuous improvements activities handling of AMS system in cooperation with IS system owner
- Defining the reporting mechanism in the Audit Management System to allow proper/meaningful reporting to the respective stakeholders being business & senior management
- Support coordination and preparation of regulatory agency inspections and other assessments by external bodies
- Handling and follow up of Product Quality Complaints (PQC)
Who are you
- Bachelor or Master degree. A first experience in a quality environment is a plus.
- Accurate and precise with the ability to plan activities and organize own work to meet deadlines
- Strong interpersonal skills resulting in an effective (intra- and cross-departmental) team player.
- A strong personality, high degree of flexibility, assertiveness and excellent communication skills
- Is system minded and has a good knowledge of current computer applications (Word, Excel, ...).
- Providing support is frequent and require excellent interpersonal skills and diplomacy.
- Fluent in English both written and spoken
What’s in it for you?
You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job 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 employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.
We are Galapagos : together we can make it happen…!