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
