- Quality 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.
- 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 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. - 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 line manager in his/her absence and approve any QO related documents.
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Quality Operations Supervisor - Singapur, Singapore - Takeda
Description
Description
Job Title: Quality Operations Supervisor
Location: Woodlands, Singapore
About 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 contribute
What you bring to Takeda:
Education and Experience Requirements
Key Skills and Competencies
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
Locations
SGP - Singapore - WoodlandsWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time
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