QA Officer

14/09/20

Location

Technologiepark-Zwijnaarde 21 Gent Belgium

Function type

Quality Systems Professional

Vacancy

QA Officer

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.

About Ablynx

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.

About you

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.

Competencies

  • 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.

Job application