Junior GLP /GcLP QA Officer
Junior GLP /GcLP QA Officer
Technologiepark-Zwijnaarde 21, Gent, Belgium
About the Opportunity
Join Ablynx, a Sanofi company as a Junior GLP/ GcLP QA Officer responsible for supporting the implementation and maintenance of the general integrated quality management system in compliance with the current GLP and GcLP requirements and Quality Management processes of Sanofi.
This full-time permanent position will be based in Ghent, Belgium.
Ablynx, a Sanofi company, is engaged in the development of Nanobodies®, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs.
Nanobodies have potential uses in the treatment of a range of serious and life-threatening human diseases. Ablynx advances a portfolio of Nanobody-based therapeutic programs in several major disease areas, including inflammation, haematology, immuno-oncology and oncology.
About growing with us
In this role, you will…
Responsible to maintain the quality management system in accordance with internal and external (inter)national standards and guidelines
Provide support, in collaboration with the operational staff, for the set-up and implementation of procedures to assure that development activities are conducted in accordance with internal and external (inter)national standards and guidelines. Perform or supervise the QA reviews of the GLP documents
Take ownership of the operational quality support of projects, incorporating the risk-based approach, assist and guide the GLP-Pharma department in quality-related topics
Responsible for the planning and timely execution of Quality Management process improvements. Responsible to perform QA inspections on study documentation and critical phases of studies
Organize and follow-up the required GLP and GcLP trainings
Perform self-inspections to verify the compliance of the Ablynx Quality Management System. Guarantee the follow-up of the corrective and preventive actions
Responsible for auditing third parties to assure that processes used and/or data generated by these third parties meet all quality standards. Establish written agreements with third parties defining the quality requirements. Guarantee the follow-up of the corrective/ preventive actions and continuous evaluation of third parties
Provide support in preparation of and act as spokesperson during regulatory and monitoring authority inspections
Qualifications/ Education & work experience
Master or PhD in a relevant field of life science with preferably 5 years of experience in a GLP regulated environment
Vision on QM and combining analytical skills with process thinking
Experience with GLP or GcLP guidelines or experience with international standards related to a laboratory setting
Experience in and affinity with GLP regulations concerning Computerized Systems is an asset
Team player, enthusiastic, independent and self-motivated
Excellent communication and writing skills are required
Sense for initiative, quality, accuracy and detail
Oral and written fluency in English, Dutch is an asset
Inspire your Journey: what Sanofi can offer you:
An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management)
An individual and well-structured introduction and training when you onboard
You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully
As a globally successful and constantly growing company, Sanofi provides international career paths as well
This is our Sanofi. Discover yours.
If you feel you have the required experience please apply, alternatively contact email@example.com directly for more details.
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