Quality Control Specialist
Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.
Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.
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Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.
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Quality Control SpecialistApply Now
Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as our Quality Control Specialist.
As our successful Quality Control Specialist, you will have oversight of Takeda Contract test laboratories utilized for release testing and on-going stability testing.
You will be responsible for the interpretation of data trends for both release and stability, life cycle of methods in alignment with the QC method development team and other technical support as required.
You will drive investigations with strong understanding of compliance and cGMP's, strong scientific judgment in decision making.
You will work with our external CMO/CTL partners and internal Quality teams. In addition, this function works closely with External Supply, Supply Planning, Technical support and other stakeholders involved in external supply.
The scope of this role spans Drug Substance and Drug Product manufactured and tested at multiple CMOs/CTLs across the region
- Building/sustaining collaborative relationships within Quality, and stakeholders across the organization
- Regularly interacting with internal and external stakeholder groups to understand needs and collaboratively resolve issues in order to meet patient and business needs
- Timely testing and reporting of accurate data
- Supporting method transfer projects and lab audits/inspections
- Supporting the establishment and revision of product specifications
- Expeditiously and objectively investigating laboratory exceptions and supporting manufacturing investigations. Escalates where further input is required
- Timely trending of data and operational key performance indicators
- Identifying and/or remediating technical, compliance, and efficiency gaps
- Anticipating, monitoring and addressing evolving and new regulatory requirements
- Authoring/reviewing regulatory submissions
- Establishing/improving technology solutions to support people and processes
- Providing accurate and timely updates of group activities to Quality and Technical Operations management with a focus on compliance, cycle times, cost management, and productivity
Key skills required
- You will have detailed knowledge of general analytical chemistry, microbiology, cell biology, protein structure/function and analysis, and characterization assays.
- Experience with commercial method implementation.
- Strong working knowledge of USP, EP, ICH, cGMP, FDA and EU requirements and guidelines
- Clear, concise communication skills, both written and spoken
- Demonstrated ability to interact professionally, to influence, and to manage conflict/differing opinions with the ability to drive solutions
- Detailed knowledge of general analytical chemistry, microbiology, cell biology, protein structure/function and analysis, and characterization assays.
- Experience with lean processes
Education, Behavioural Competencies
- Ph.D. in Chemistry, Biology or other related fields with >3 years of relevant Postdoctoral/Industrial experience or BSc/MSC with >6 years of relevant experience.
- Thorough understanding of quality systems and cGMPs.
- Experience conducting lab audits and/or involvement in preparation for Health Authority inspections.
- Interpersonal skills and communication skills to interact with CMO/CTL partners and other functions.
- Must be able to prioritize in a busy environment.
- Must be available to travel -approx 20% (domestic and international)
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Job ID SR0039030