Vie - Quality & Regulatory Assurance Coordinator m/F

Descrizione del lavoro:

EUROAPI is focused on reinventing active ingredient solutions to sustainably meet customers' and patients' needs around the world. We are a leading player in active pharmaceutical ingredients with approximately 200 products in our portfolio, offering a large span of technologies, while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities.

Taking action for health by enabling access to essential therapies inspires our 3,450 people every day. With strong research and development capabilities and six manufacturing sites all located in Europe (Saint-Aubin-lès-Elbeuf and Vertolaye in France, Brindisi in Italy, Frankfurt in Germany, Budapest in Hungary and Haverhill in the UK), EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries.

EUROAPI is listed on Euronext Paris.
Your responsibilities: Customer Request & Complaints: * Collect, handle and follow-up on customer requests and complaints * Coordinate investigation work on deviations and non-conformities in cross-functional teams * Initiate and assure the follow-up of open CAPA (Corrective Action Preventive Action) Regulatory Dossier Management * Track, Monitor and support Change Control (CCAF) and its proper review * Contribute to regulatory assessment projects for specific client needs * Participate in client meetings Quality & Regulatory Management Framework: * Participate in the continuous improvement of the Quality & Regulatory Management Systems * Participate to the update of the Standard Operating Procedures * Ensure compliance of product shipments with regulatory standards (FDA, EMA, ICH, ISO…) * Ensure proper recording of all QARA activities in global tracking & reporting systems

Requisiti del candidato:

Master's degree in Quality Management, Quality Engineering or Regulatory Affairs 2-3 years of professional experience (experience in pharma is a plus) Good understanding of Global Quality & Good Manufacturing Practices (GMP) standards Basic understanding of North America Health Rules & Regulations (ex: FDA guidelines) Strong data analytics skills and ability to manage large volume of information Excellent project management skills and analytical skills Demonstrates ability for teamwork and interaction with multiple stakeholders English is mandatory and French is a plus