GMP QA Officer

le contenu du travail

GMP QA Officer / Management Specialist

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.

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