Takeda
QualityOperationsSpecialistI/II
Neural analysis suggests this role is
optimal for Entry candidates.
“Quality Operations Specialist I/II at Takeda. Skills: Quality oversight, GMP compliance, Process improvements. Ensure quality oversight. Partner manufacturing team”
Industry & Context.
Logically solve problems; Find timely solutions
Out-of-hours support
What They're Looking For.
Must Have
Degree in pharmaceutical sciences, Degree in life sciences, Degree in biology, Degree in biotechnology, Degree in chemistry, Degree in chemical engineering, Degree in related discipline
Nice to Have
Minimum 0-2 years experience, Experience in pharmaceutical industry, Experience in biotechnology industry, Experience in quality assurance, Experience in GMP/GLP compliance, Experience in manufacturing operations, Experience in validation, Experience in multinational company, Hands-on experience upstream, Hands-on experience downstream, Cell culture experience, Cell expansion experience, Fermentation experience, Media preparation experience, Purification experience, Column packing experience, Product release knowledge
What You'll Do.
Ensure quality oversight
Partner manufacturing team
Implement quality systems
Adhere to GMP requirements
Participate in meetings
Support compliance activities
Support regulatory activities
Support inspections activities
Support training activities
Support development of SOPs
Support writing of SOPs
Support development of master batch records
Support writing of master batch records
Ensure compliance with current good documentation practices
Ensure compliance with global procedures
Ensure compliance with regulatory requirements
Take ownership for investigations
Review executed manufacturing batch records
Approve revision of MBR
Participate as SME in gap analysis
Ensure compliance with revision of global procedures
Ensure implementation plan is in place
Follow-through to completion
Participate in cross-functional investigations
Support quality interpretation
Render timely support for release of Bulk Drug
Resolve BDS release matters
Provide QO related impact assessments
Take ownership of change controls
Participate in routine GMP walk-through
Participate in process improvements
Participate in process studies
Perform timely archival of QO documents
Manage BDS reference samples
Provide out-of-hours UI request support
Provide out-of-hours queries support
Build partnership with departments
Ensure open communications
Adhere to EHS requirements
How You'll Work.
Team & Collaboration
Partner manufacturing team; Cross-functional investigations; Build partnership with departments
Full Job Description
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](https://jobs.takeda.com/privacynotice) and [Terms of Use](https://www.takeda.com/terms-and-conditions/). I further attest that all information I submit in my employment application is true to the best of my knowledge. ## **Job Description** **About This Role:** This position is a member of the Quality Operations (QO) team in providing quality oversight to the manufacturing team to ensure GMP compliance at Takeda Singapore. **Responsibilities** • Quality Systems Representative ➢ Member of the QO team in ensuring quality oversight at the manufacturing suite ➢ Partner the manufacturing team in the implementation and adherence to the various quality systems and GMP requirements at the manufacturing suite ➢ Participate in meeting with the manufacturing for information learning/sharing and alignment of best practices ➢ Support the compliance, regulatory, inspections and training activities as required and any other responsibilities as assigned by supervisor. • QO Operations ➢ Revise & participate in the development and writing of procedures pertaining to the QO operations. ➢ Support the manufacturing team with development and writing of process standard operating procedures and master batch records ensuring compliance with current good documentation practices and the applicable global procedures and regulatory requirements. ➢ Take on ownership for investigation relating to quality operations. ➢ Review executed manufacturing batch records (MBR) and approve revision of MBR ➢ Participate as SME in the gap analysis for current SOP/ practices with the various subject matter expert to ensure compliance with revision of global procedures, where gaps are identified, ensure that an implementation/ mitigation plan is in place and follow-through to completion. ➢ Part
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