Technologiepark-Zwijnaarde 21 Gent Belgium
Quality Systems Professional
About the Opportunity
As a QA officer at Ablynx, you will play an important part in developing qualitative nanobody products for use in phase 1 clinical trials. You will liaise with internal and external stakeholders and work together with the organisation to install a quality mindset using a pragmatic approach.
Ablynx, a Sanofi company, is a biopharmaceutical company dedicated to creating new antibody-based medicines called Nanobodies® which are making a real difference to society. Ablynx currently has over 400 people working on the development of Nanobodies for the treatment of a wide range of diseases, including inflammation, immuno-oncology and rare diseases.
About growing with us
In this role you will be …
Responsible to support the set-up and maintenance of a quality management system in accordance with internal and external (inter)national standards and guidelines.
Responsible to support the definition, set-up and implementation, in collaboration with the operational staff, procedures to assure development activities are conducted in accordance with internal and external (inter)national standards and guidelines.
Provide operational quality support of projects, incorporating the risk-based approach.
Responsible to support the planning and timely execution of Quality Management process improvements and timely implementation of new or updated procedures.
Responsible to perform a QA review on project documentation.
Responsible to support the organization and follow-up the required trainings.
Responsible to perform internal audits to verify the compliance of the Ablynx Quality Management System. Guarantee the follow-up of the corrective and preventive actions.
If applicable, responsible for auditing third parties to assure that processes used and/ or data generated by these third parties meet all quality standards. Establish written agreement with third parties defining the quality requirements. Guarantee the follow-up of the corrective action/ preventive actions and continuous evaluation of third parties.
Responsible to provide support in preparation of and act as spokesperson during regulatory inspections.
Qualifications/Education & work experience
Scientific bachelor with knowledge of applicable GxP regulated environment.
QP qualification would be an added value.
Familiar with regulated environment (pharmaceutical) and inspections.
Knowledge of validation principles applicable to the pharmaceutical industry.
Sufficient scientific knowledge allowing to understand the test procedures although no technical skill is required.
Experience in the pharmaceutical and/ or Biotechnology industry.
Experience with document control systems.
Knowledge of health authority’s guidelines and regulations regarding GxP/ R&D.
Good knowledge of MS Office.
Impact of Decisions: very good communication and negotiation skills (auditor), proactive.
Organizational skills: good organization skill to be able to follow multiple studies and audits.
Very good knowledge of English (written and spoken).
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 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.