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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

Interaction:

  • 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

Innovation:

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

Complexity:

  • 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

APPLY HERE

Shekhar
Shekhar
Shekhar Suman is the Co-founder of BioTecNika Info Labs Pvt. Ltd. He is an Entrepreneur, Writer, Public Speaker, and a Motivational Coach. In his career, he has mentored more than 100,000+ students toward success in the Biopharma Industry. He heads the BioTecNika Group, which comprises BioTecNika.com, BioTecNika.org, and Rasayanika.com. An avid reader and listener who is passionate about BioSciences. Today Biotecnika is India's largest Biotech Career portal, with over 5 Million subscribers from academia & Industry. It's ranked among the top 50 websites worldwide in the Biology category.
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