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Senior Quality Operations Specialist I
Primary Objectives of this Job
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.
• Quality Systems Representative
o Member of the QO team in ensuring quality oversight at the manufacturing suite.
o Partner the manufacturing team in the implementation and adherence to the various quality systems and GMP requirements in the manufacturing suite.
o Lead meetings with the manufacturing for information learning/ sharing and alignment of best practices.
o Support the compliance, regulatory, inspections and training activities as required and any other responsibilities as assigned by Supervisor.
• QO Operations
o Revise, develop and write procedures pertaining to QO operations.
o Support the manufacturing team with development and writing of process Standard Operating Procedures and Master Batch Records and ensure that it complies with current good documentation practices and the applicable global procedures and regulatory requirements. This includes approval of the associated revision.
o Take on ownership of investigation relating to quality operations.
o Review executed Manufacturing Batch Records (MBR) and approve revision of MBR.
o Lead and participate as SME in the gap analysis for current procedures/ practices with the various subject matter expert to ensure compliance with revision of global procedures.
o Where gaps are identified, ensure an implementation/ mitigation plan is in place and follow-through to completion.
o Provide QO related impact assessments for change controls and own change controls relating to quality operations.
o Participate and lead in cross-functional investigations.
o Review and approve standard operating procedures.
o Support the manufacturing team with any quality interpretation, queries and issues.
• Other responsibilities (if assigned)
o Ensure timely release of Bulk Drug Substances (BDS) and resolution of BDS release matters.
o Be document owner for SOPs related to quality operations.
o Lead/ Participate in routine GMP walk-through with manufacturing team.
o Participate and lead in process improvements/studies with the manufacturing team and draft/approve test scripts/protocols.
o Ensure timely archival of QO documents.
o Manage Cell Bank and BDS Reference Samples.
o Build strong partnership with all other departments to ensure open communications and acceptance.
• Responsibility to adhere to any applicable EHS requirements.
• Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.
• Any other duties as assigned by supervisor.
Education and Experience Requirements
• The candidate should have at least a degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, or related discipline.
• A minimum experience of 5 years in the pharmaceutical or biotechnology in quality assurance, GMP/GLP compliance, manufacturing operations or validation, ideally in a multinational company. Hands-on experience with upstream (e.g cell culture, cell expansion, fermentation, media preparation etc), downstream (e.g purification, column packing, etc) will be of advantage.
• Understanding of FDA/EU and ICH guidelines, any exposure/experience to the international regulatory network will be of advantage.
• Demonstrate ability to collaborate with cross functional or cross sites to achieve objectives.
• Six sigma greenbelt training would be helpful.
Key Skills and Competencies
• Equip with good knowledge of quality systems.
• Equip with good knowledge in the various regulatory requirements.
• Equip with good presentation skills.
• Able to solve problems in a logical manner with timely solutions.
• Able to interact and communicate with all types of personalities in an effective and diplomatic manner.
• Project management skills is preferred.
• Product Release knowledge is preferred
• Be a delegate for QO Supervisor in his/her absence and approve any QO related documents.