Takeda
QualityOperationsSpecialistI/II
“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
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