Quality Assurance GMP Specialist

4 settimane fa


Milano, Lombardia, Italia Fondazione Telethon ETS A tempo pieno

Fondazione Telethon ETS is a leading organization dedicated to developing therapeutic options for patients affected by rare genetic disorders. Our pipeline consists of various programs at different development stages, from pre-clinical to commercial. As part of our commitment to quality, we are seeking a Quality Assurance GMP Specialist to support our QA Unit in the maintenance, management, and development of our Quality Management System, with a focus on GMP Quality Assurance.

The primary objective of this position is to collaborate closely with the QA Unit, CMC Unit, Regulatory Affairs Unit, Supply Chain Unit, and external vendors to ensure the quality of our products and services. Key responsibilities include:

  • Supporting the QA unit in the quality oversight of external GMP vendors, including suppliers qualification, handling of external quality events, and handling of external change controls;
  • Managing internal change controls and non-compliances, including root cause investigations, to evaluate and resolve quality issues and enhance continuous improvement;
  • Supporting the Supply Chain function in guaranteeing that subcontracted storage and distribution activities are conducted following GDP principles and product-specific requirements;
  • Maintaining and improving the existing Quality Management System through writing/revision of SOPs;
  • Providing personnel training to GMP-related documents and tasks;
  • Assisting the QA unit in the preparation and conduction of regulatory inspections and self-inspections.

Requirements include a degree in a relevant scientific discipline, previous experience in Quality Assurance, preferably GMP, and excellent English oral and written communication skills. Ability to work autonomously and prioritize workflow is also essential.



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