GMP QA Officer / Management Specialist
Sanofi
Gent
5 dagen geleden

About the opportunity

Join Ablynx as GMP QA Officer / Management Specialist to manage the daily quality activities of the Ablynx GMP QC laboratory.

In this role, your main responsibilities are to set-up, implement and follow up the implementation and maintenance of the Quality Management System in compliance with the GMP requirements.

You will be working in an organisation where a Quality mindset runs through all aspects of operations.

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

  • Set-up and maintain the quality management system of the GMP QC laboratory in accordance with internal and external (inter)national standards and guidelines
  • Support the definition, set-up and implementation, in collaboration with the operational staff, of procedures to assure development activities are conducted in accordance with internal and external (inter)national standards and guidelines
  • Operational quality support of projects, incorporating the risk-based approach
  • Plan and timely execution of Quality Management process improvements and timely implementation of new or updated procedures
  • Perform QA reviews on project documentation
  • Organize and follow-up the required trainings
  • Perform internal audits to verify the compliance of the Ablynx Quality Management System. Guarantee the follow-up of the corrective and preventive actions
  • Audit 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

  • Provide support in preparation of and act as spokesperson during regulatory inspections
  • About you

    Qualifications / Education & work experience

  • Master or PhD in a relevant field of life sciences
  • 3-5 years of experience in the pharmaceutical and / or Biotechnology industry
  • Knowledge of applicable GMP regulated environment
  • Experience with document control systems
  • Knowledge of health authority’s guidelines and regulations regarding GMP
  • Good knowledge of MS Office
  • Very good knowledge of English (written and spoken)
  • Competencies

  • Excellent negotiating and influencing skills
  • Good organization skills to be able to follow multiple studies and audits
  • Hands-on approach
  • 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.

    We are proud to have been awarded Global Top Employer 2021.

    At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers.

    We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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