Quality Assurance Manager & Technical Responsible

Daiichi Sankyo Europe GmbH; Madrid; On-site; EUR 60,000 - 100,000; Full time

Job summary

Daiichi Sankyo Europe GmbH in Madrid is seeking a Quality Assurance professional to support the GMP/GDP Team Cluster Lead, developing and coordinating activities to ensure compliance with good distribution and manufacturing practices.

You will manage technical documentation, quality issues, and interactions with Health Authorities, lead GDP trainings, and collaborate with Supply Chain and Regulatory functions to uphold the company quality management system.

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 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. And deciding on the final disposition of returned, rejected, recalled or falsified 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 department in matters related to Quality.
• Contact person with third parties related to quality matters (warehouse subcontracted, distributors, Hospitals, Pharmacies..)

Job description

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 global 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 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. And deciding on the final disposition of returned, rejected, recalled or falsified 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 department in matters related to Quality.
• Contact person with third parties related to quality matters (warehouse subcontracted, distributors, Hospitals, Pharmacies..)

Further Responsibilities

• Support to other company departments at local and Global level. ( i.e. : product launch and advice..)
• Maintain constant contact with Regulatory functions in DSES/DSE and Quality functions in DSE.
• Ensuring relevant customer Quality complaints are dealt with timely and effectively.
• Approving subcontracted activities which may impact on GDP.
• Coordinating and promptly performing any recall operations for medicinal products in DSES.