Quality Operations Supervisor
Takeda
- Woodlands, Singapore
- Permanent
- Full-time
Location: Woodlands, SingaporeAbout the role:This position is required to lead the Quality Operations team in providing quality oversight to the manufacturing team to ensure GMP compliance at Takeda Singapore.How you will contributeQuality Systems Representative
o Lead a team of QO Specialists in providing quality oversight to the manufacturing suite.
o Lead a team of QO Specialists to partner the manufacturing team in the implementation and adherence to the various Quality systems and GMP requirements at the manufacturing suite.
o Participate in any corporate/ divisional alignment meetings for information learning & sharing and alignment of best practices.QO Operations
o Lead a team of QO Specialists to ensure timely review and approval of master batch records and standard operating procedures.
o Lead a team of QO Specialists to ensure timely release of Bulk Drug Substances and review of completed manufacturing batch record.
o Lead a team of QO Specialists to perform routine GMP walk-through with manufacturing team in a timely manner.
o Lead a team of QO Specialists to support and approve quality operations and manufacturing gap analysis for current procedures/practices with the various subject matter expert to ensure compliance with revision of global procedures and propose mitigation plans where gaps are identified.
o Lead a team of QO Specialists to ensure timely archival of QO documents and proper management of Cell Bank and BDS Reference Samples.
o Participate and lead in process improvements/ studies with the Manufacturing team.
o Participate and lead in cross-functional investigations.
o Support the compliance, regulatory, inspections and training activities as required and any other responsibilities as assigned by supervisor.Leadership
o Manage, coach and develop QO specialists and contribute to the growth of those professionals.
o Ensure succession planning by identifying and groom high potential employee to be the successor for the QO supervisor role to ensure business continuity.
o Build strong partnership with all other departments to ensure open communication 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.What you bring to Takeda:Education and Experience RequirementsThe candidate should have at least a degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, or related discipline.A minimum experience of 7 years (with at least 3 years in senior position) in the pharmaceutical or biotechnology in quality assurance, GMP/GLP compliance, operations or validation, ideally in a multinational company.Understanding of FDA/EU and ICH guidelines and any exposure/experience to the international regulatory network/audits will be of advantage.
- Six sigma greenbelt certification would be of advantage.