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.

➢ Participate in cross-functional investigations where assigned.

➢ Support the manufacturing team with any quality interpretation, queries and issues.

. Other responsibilities (if assigned)

➢ Render timely support for the release of Bulk Drug Substances (BDS) and resolution of BDS release matters

➢ Provide QO related impact assessments for change controls and take on ownership of change controls relating to quality operations.

➢ Participate in routine GMP walk-through with the manufacturing team.

➢ Participate in process improvements/studies with the manufacturing team and draft test scripts/ protocols.

➢ Perform timely archival of QO documents.

➢ Manage cell bank and BDS reference samples.

➢ Provides out-of-hours User Intervention (UI) request support and queries per rotational basis

.Leadership

➢ 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. . Preferable a minimum experience of 0 - 2 years in the pharmaceutical or biotechnology in quality assurance, GMP/GLP compliance, manufacturing operations or validation, preferably 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.

Key Skills and Competencies

. Equip with good knowledge of the quality systems.

. Equip with good knowledge in the various regulatory requirements.

. Equip with product release knowledge is preferred.

. Able to logically solve problems in order to find timely solutions.

. Able to interact and communicate with all types of personalities in an effective and diplomatic manner.

Quality Operations Specialist I/II