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LOC Quality and MAH EU Specialist

2 months ago

Vallensbæk Strand, Denmark Takeda Pharma AS Full time

Description

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.

How you will contribute:

Product Quality Review and Marketing Authorization:

Maintain overview of Takeda Pharma A/S MA ownership including PQR review

Prepare, maintain and perform PQR review annual plan.

Stakeholder management with internal and external partners

Prepare monthly the KPI for PQR and Quality agreement.

Processing of deviations, CAPA’s and change control:

Act as aTrackWise (TW) owner, subject matter expert (SME) and quality approver

Prepare and participate Audits and inspection observations

Initiatiate, own, evaluate and review deviations, CAPAs and change controls in TrackWise

Act as quality approver locally as well as cross borders in the Nordics

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

What you bring to Takeda:

University degree in Life Sciences or a related discipline, pharmacy preferred

Experience from the pharmaceutical industry (GXP)

Excellent knowledge in local and international GMP / GDP regulations

Strong communication and stakeholder management skills.

Fluent English (C1) and Danish is a must

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.

Empowering our people to shine:

Locations DNK - Vallensbæk

Worker Type Employee

Worker Sub-Type Regular

Time Type Full time