Expert GMP/GDP QA Affiliate Support -(m/w/d)

Expert GMP/GDP QA Affiliate Support -(m/w/d)

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Daiichi Sankyo Europe GmbH
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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Daiichi Sankyo Europe GmbH

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Daiichi Sankyo Europe GmbH Recruiting-Team