LOC Quality and MAH EU Specialist

2 weeks ago


Vallensbæk Kommune, Denmark Takeda Full time

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.

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:
  1. Product Quality Review and Marketing Authorization:

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

  3. Prepare, maintain and perform PQR review annual plan.

  4. Stakeholder management with internal and external partners.

  5. Prepare monthly the KPI for PQR and Quality agreement.

  1. Processing of deviations, CAPA’s and change control:

  2. Act as a TrackWise (TW) owner, subject matter expert (SME) and quality approver.

  3. Prepare and participate in Audits and inspection observations.

  4. Initiate, own, evaluate and review deviations, CAPAs and change controls in TrackWise.

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

  1. General responsibilities:

  2. Be part of LOC Quality Council.

  3. Take care of proper archiving, documentation, and data integrity.

  4. Support projects to contribute to the compliance with GDP regulation in LOC Denmark.

  5. Take care of proper archiving, documentation and data integrity related.

What you bring to Takeda:
  1. University degree in Life Sciences or a related discipline, pharmacy preferred.

  2. Experience from the pharmaceutical industry (GXP).

  3. Excellent knowledge in local and international GMP / GDP regulations.

  4. Strong communication and stakeholder management skills.

  5. 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:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

Locations:

DNK - Vallensbæk

Worker Type:

Employee

Worker Sub-Type:

Regular

Time Type:

Full time

#J-18808-Ljbffr

  • Vallensbæk Kommune, Denmark Takeda Pharmaceutical Full time

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...


  • 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...


  • Vallensbæk Strand, Denmark Takeda 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...


  • Vallensbæk Strand, Vallensbæk Kommune, Denmark Takeda Pharma AS Full time

    About the role:LocationsDNK - VallensbækWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time


  • Struer Kommune, Denmark Danfoss AS Full time

    Requisition ID: 38892 Job Location(s): Kolding, DK; Nordborg, DK; Silkeborg, DK Job Description Danfoss is proud to be at the forefront of driving a global transformation in digital and electric solutions that increase productivity and energy efficiency. We are truly passionate about investment and innovation as we continue to support our customers'...


  • Struer Kommune, Denmark Danfoss Full time

    Job Description Danfoss is proud to be at the forefront of driving a global transformation in digital and electric solutions that increase productivity and energy efficiency. We are truly passionate about investment and innovation as we continue to support our customers' journey towards a greener and lower-carbon future. Our Hydronics team is proud to...

  • Director, Quality

    2 weeks ago


    Glostrup Kommune, Denmark Oil and Gas Job Search Ltd Full time

    Job Description We are a leading engineering and manufacturing company specializing in subsea production systems for the oil and gas and industrial sectors. With a commitment to innovation, sustainability, and operational excellence, we provide energy solutions to our clients worldwide. Our dedication to quality is at the forefront of our operations,...


  • Glostrup Kommune, Denmark Agilent Technologies Full time

    Field Action Specialist Job Description The Global Quality and Regulatory Affairs (GQRA) Field Action Specialist’s responsibilities include managing Field Action Activities such as leading Field Action Strategy and Field Safety Communication meetings, recalls, field notifications, and correction processes for medical and non-medical products. Duties...


  • Gladsaxe Kommune, Denmark AGC Biologics Full time

    The Position You will be a part of the QC Stability Team which is a part of Quality Control handling stability studies of Drug Substance, Drug Product, Placebo, and Reference Material. Your working day is characterized by ongoing collaborations with stakeholders such as customers, project managers, management, your own department, and QA. Along with your...


  • Gladsaxe Kommune, Denmark AGC Biologics Full time

    Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. Would you like to be a part of AGC Biologics' growing success? We are...


  • Gladsaxe Kommune, Denmark AGC Biologics Full time

    Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. AGC Biologics is looking for an experienced QA scientist to assist with...


  • Aarhus kommune, Denmark RDT Ingeniører ApS Full time

    We are looking for a Communications Specialist for our client in the pharma industry. Location: Greater Copenhagen, hybrid. QUALIFICATIONS & COMPETENCIES Experience in managing and updating SharePoint pages – including layouts. Strong design skills with experience in creating newsletters and presentations. Proficiency in Microsoft Office Suite, especially...


  • Gentofte Kommune, Denmark Best Talent Full time

    The Company Ascendis Pharma A/S, a U.S. publicly held biopharmaceutical company founded in Copenhagen, Denmark in 2007, is committed to addressing unmet medical needs. Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by...


  • Gladsaxe Kommune, Denmark AGC Biologics Full time

    Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. About the Job Do you thrive in a fast-paced environment? Are you...


  • Gladsaxe Kommune, Denmark Novo Nordisk Full time

    QA Specialist Assembly & Packaging or Tablets Category: Quality Location: Søborg, Capital Region of Denmark, DK Join Global Contract Manufacturing (GCM) – Drug Product (DP) QA and contribute with tablets, assembly, packaging and compliance specialist experience. Our team supports CMO assessments, operation support and transfer projects to CMOs in...


  • Aarhus kommune, Denmark Intl. N&H Denmark ApS Full time

    Senior Application Specialist Job Summary IFF, a global leader in dairy solutions, is seeking a dynamic and experienced Fresh Fermented Senior Application Specialist to join our EMEA Cultures Application team in Brabrand, Denmark. As a Fresh Fermented Senior Application Specialist, you will be responsible for providing technical support and expertise to our...

  • QA Specialist

    2 weeks ago


    Gladsaxe Kommune, Denmark Novo Nordisk AS Full time

    Jobbeskrivelse Placering Bagsværd, Denmark Jobkategori Quality Ansøg nu We are looking for a skilled QA specialist, to take part in a strong, evolving, and fast-moving organisation with a significant role in securing the quality and safety of Novo Nordisk's products. Does this sound like a job for you? Then you may be the person we are looking for to...


  • Aarhus kommune, Denmark K2 Management AS Full time

    Would you like to work on quality projects in one of the most dynamic and international organizations within the booming renewable industry? At K2 Management, we’re on the hunt for a Project Quality Manager for our HSEQ & Risk Management team. We’re an exciting, independent renewable energy consultancy with over 15 offices around the world employing...

  • Technical Sourcing

    2 weeks ago


    Gladsaxe Kommune, Denmark European Energy AS Full time

    Your new team The Technical Sourcing Manager will be part of our EPC Sourcing & Procurement team, which is part of European Energy’s EPC department. The EPC department holds the overall responsibility for the design, planning, procurement, and management of our projects during the ready-to-build and construction phase. We work with professional suppliers,...


  • Glostrup Kommune, Denmark Agilent Technologies Full time

    Regulatory Affairs Specialist, IVDR Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do...