Uncover the Exciting Job of an External QC Specialist in Dublin, Ireland – Apply Now

QC Jobs in Ireland – Takeda is Hiring – Apply Below

QC Jobs in Ireland, At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to inspires and empowers you to grow through life-changing work.

Role: External QC Specialist

Job ID: R0108755

Location: Dublin, Ireland

About the role:

  • QC oversight management of Takeda Contract test laboratories used for release and ongoing stability testing
  • Interpret data trends for both release and stability, life cycle of methods, and other technical support.
  • Lead investigations with the understanding of compliance and cGMPs, scientific judgment, and leadership in decision-making.
  • Optional hybrid work model.

How you will contribute:

  • Anticipate and fill capability gaps that may arise as new technologies are acquired
  • Building/sustaining collaborative relationships within EU Quality, and across the organization
  • Work with partner (e.g. Regulators) groups to understand needs and collaboratively resolve issues
  • Test and reporting of accurate data
  • Support and build method transfer projects and lab audits
  • Support the establishment and revision of product specifications
  • Expeditiously and objectively investigating laboratory exceptions and supporting manufacturing investigations
  • Trend of data and operational measurements
  • Identify and fix technical, compliance, and efficiency gaps
  • Anticipate, monitor, and address evolving regulatory requirements
  • Review regulatory submissions
  • Establish/improve technology solutions to support people and processes
  • Provide accurate updates of group activities to International Quality and EU Technical Operations management with a focus on compliance, cycle times, cost management, and productivity

Technical/Functional (Line) Expertise:

  • Review regulatory submissions of CMC sections
  • Detailed knowledge of general analytical chemistry, microbiology, cell biology, protein structure/function and analysis, and characterization assays.
  • Experience with commercial and clinical development method implementation.
  • Working knowledge of USP, EP, ICH, cGMP, FDA, and EU requirements and guidelines
  • Experience working with contract testing laboratories
  • Represent EU QC function at internal/external meetings including interactions with global regulatory bodies

Decision-making and Autonomy:

  • Define problems and draw conclusions or provide recommendations based on limited data, as it relates to technical, regulatory/compliance, and operational issues.
  • Participate in the External Quality Control Leadership team in making decisions regarding overall Quality priorities within the EU


  • Collegial, “team player” who can excel within both a line and matrix organization, and within a global, multi-site/multicultural context
  • Demonstrated ability to manage conflict/differing opinions with the ability to find solutions


  • Detailed knowledge of general analytical chemistry, microbiology, cell biology, protein structure/function and analysis, and characterization assays.
  • Experience with lean processes


  • Working knowledge of cGMP compliance, knowledge of regulatory requirements relating to Quality Control of bio/pharmaceuticals.
  • Monitor all operations and project-related activities and take action to ensure delivery of goals and to meet KPIs
  • Experience operating with internal and external partners

What you bring to Takeda:

  • Ph.D. in Chemistry, Biology, or other related fields with >2 years of relevant Postdoctoral/Industrial experience, MSc. with >4 years of relevant experience, or BSc with >8 years of relevant experience.
  • Some business travel is required, including international travel.

What Takeda can offer you:

  • Full Healthcare Cover – includes dependents
  • Pension Scheme
  • Attractive Bonus
  • Subsidized canteen
  • Parking facilities with electric car charging points
  • Health and wellness programs including onsite flu shots and health screenings
  • Educational Assistance



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