08 oct
|
Daiichi Sankyo Europe
|
Madrid
08 oct
Daiichi Sankyo Europe
Madrid
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative general healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Roles and Responsibilities
• Provide support to the GMP/GDP Team Cluster Lead in addressing and coordinating local activities and requirements, as needed.
• Develop functions established in the current legislation to the Marketing Authorization Holder, in the field of the storage and distribution of medicinal products, according to the good distribution practices, to ensure their implementation and compliance.
• Ensure the implementation of good manufacturing practices to third parties under contract.
• Authorize the placing on the market of medicinal products after documentation review.
• Be responsible for the technical documentation concerning laboratory authorization and quality issues.
• Signature of technical documents (technical agreements, declarations and documents related to quality issues).
• Contact person with Health Authorities concerning inspection and control of medicines and/or quality matters.
• Assure the implementation, maintenance and follow up of the Quality management system GDP (change controls, risk management, subcontracted activities, quality indicators, quality system review).
• Be responsible for the compliance and implementation of the GDPs across the company.
• Training on GDP to company employees.
• Management of related to GMP/GDP local nonconformities, quality incidences and CAPA ́s
• Elaboration of GDPs: technical documentation, documents management and archive (concerning qual
📌 Quality Assurance Manager (Madrid)
🏢 Daiichi Sankyo Europe
📍 Madrid