update 7 days ago
GLP Quality Assurance Coordinator F/M
  • Ref: CAQ/2021/12/WEB
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Company presentation

Adocia is 110-people biotechnology company based in Lyon, listed on the Euronext stock exchange, and specialized in the development of innovative formulation of previously approved proteins. Adocia's insulin formulations portfolio, featuring five products in clinical stage and three in preclinical stage, is among the largest and most differentiated in the industry.

Your mission

ADOCIA is recruiting a GLP Quality Assurance Coordinator F/M for their Quality Assurance department.

Reporting to the Assurance Quality Manager, you are a key player in the implementation and monitoring of the quality system and its improvement in accordance with the different applicable regulations.

Your main mission will be to participate actively in the process of managing non-clinical regulatory trials which will include:

  • Quality support for the production of trial elements
  • Certification of subcontractors and monitoring of associated actions
  • Quality support for subcontracted activities: protocol reviews and reports, QA support for conducting the trial
  • Annual evaluation of subcontractors and implementation of improvements if necessary
  • Continual improvement of the process linked to this activity

This position requires regular business trips in France and Europe. In an evolving quality context, you will also participate in the continuous improvement approach by taking part in internal audits and in the management of CAPA. You support the company in the advancement of product development.

Expected profile

With Pharmacist, Engineer or Masters' level training with experience in GPL quality, you have at least 3 years of professional experience in the pharmaceutical industry, biotechnology or at a non-clinical CRO.

Good knowledge of the Good Laboratory Practices frame of reference, good English, and the ability to coordinate audits in an international context are necessary.

Knowledge of the Good Clinal Practices frame of reference would be an advantage.

You are rigorous and like your work to be well done. You have developed good communication and information sharing skills.

You are a driving force for proposals and improvements, and you know how to instill the quality spirit within operational organizations.

Finally, you have a strong team spirit.

Passionate about Science and Innovation, curious and active when facing challenges, working in an ambitious, competitive, and promising field motivates you.

Adocia promotes excellence to become a partner of choice for leading pharmaceutical companies specializing in innovative treatments for chronic diseases.

 

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