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
- 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
- Lead meetings 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 and participate in the development and writing of procedures pertaining to the QO operations
- Support 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.
- Take on ownership of 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 an implementation/ mitigation plan is in place and follow-through to completion.
- Participate in cross-functional investigations.
- Support the manufacturing team with any quality interpretation, queries and issues
- Other responsibilities (if assigned)
- Render support for timely release of Bulk Drug Substances (BDS) and resolution of BDS release matters
- Provide QO related impact assessments for change controls and own change controls (relating to Quality Operations)
- Review and approve standard operating procedures
- Lead/ Participate in routine GMP walk-through with manufacturing team
- Participate in all 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
- Build strong partnership with all other departments to ensure open communications and acceptance
- Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda s Code of Conduct.
- Responsibility to adhere to any applicable EHS requirements.
- 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 2 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.
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.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.