LOC Quality and MAH EU Specialist (m/f/d)

at  Takeda Pharmaceutical

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MORE ABOUT US:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

ABOUT THE ROLE:

As Local Quality and MAH (Marketing Authorization Holder) EU Specialist you perform the Quality MAH obligations for Takeda Pharma A/S participating in the maintenance of Local and Nordic actions. In this multifaceted role, you will be responsible for change control, deviation, CAPA management, trainings, document management as well as audits and self-inspections (internal and external) among other things. You work as a deputy responsible person in Denmark as agreed with and delegated from the RP and report to Gitte Hjelvang, the Head of Quality DK & Nordics bei Takeda.

GENERAL RESPONSIBILITIES

• Be part of LOC Quality Council
• Take care of proper archiving, documentation, and data integrity
• Support projects to contribute to the compliance with GDP regulation in LOC Denmark.
• Take care of proper archiving, documentation and data integrity related