13 oct
|
Daiichi Sankyo Europe
|
Madrid
13 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. Provide support to the GMP/GDP Team Cluster Lead in addressing and coordinating local activities and requirements, as needed.
Ensure the implementation of good manufacturing practices to third parties under contract.
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).
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 quality manual, laboratory authorization, procedures, reports of support, certificates of analysis, certificates of conformity, delivery documentation, technical agreements, contract of services and quality issues).
Management of returns, destruction of expired products. Planification and coordination of GDP Self inspections and quality audits.
Compile and management of pharmaceutical legislation related to Quality and Pharmaceutical Distribution.
Collaboration with Supply Chain d
📌 Quality Assurance Manager (Madrid)
🏢 Daiichi Sankyo Europe
📍 Madrid