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.
The Position
The Quality Expert – Daiichi Sankyo EU Affiliate Support will be responsible to provide operative support to the local QA Managers of a defined country cluster. In addition, he will support the local Responsible Persons according to the European GDP Guideline.
Roles and Responsibilities
* Registration and follow‑up of complaints, returns, deviations, changes, and CAPAs
* Support the Quality Manager/RP in updating GxP‐relevant SOPs
* Management and administration of trainings
* Support of customer qualification activities
* Participation in self‑inspections
* Assist in preparation of annual management review
* GDP product release support
* Support of country‑specific QA projects
* Deputize local Quality Manager/RP
Personal Skills and Professional Experience
* University/FH/Master's degree in natural or pharmaceutical sciences, preferably in Pharmacy, Chemistry, or a comparable program
* At least 2 years of relevant work experience in the pharmaceutical industry in Quality Assurance and/or Quality Management
* Knowledge of European GMP/GDP regulations
* Team player with high quality consciousness, accurateness, reliability, and a solution‑oriented mindset
* Very good written and verbal communication skills in English; additional European languages (e.g. Italian, Spanish, French) are an advantage
Benefits
Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas.
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