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Job 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 a Track Wise (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 Track Wise
  
• 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
  

Locations

DNK - Vallensbæk

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time