Takeda

QualityOperationsSpecialistI/II

S$58–78k ~AI est. Singapore, Singapore FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Entry candidates.

The Brief

“Quality Operations Specialist I/II at Takeda. Skills: Quality oversight, GMP compliance, Process improvements. Ensure quality oversight. Partner manufacturing team”

Industry & Context.

Problems you'll solve

Logically solve problems; Find timely solutions

Eligibility Requirements

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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