Qo Specialist Ii
2 weeks ago
Job Title:
QO Specialist II
Location:
Woodlands Singapore
Reporting to:
Quality Operations Supervisor
About the 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.
How you will contribute:
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
- 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 in crossfunctional investigations.
- Support the manufacturing team with any quality interpretation, queries and issues
- 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 walkthrough 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
- 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 Requirements
- 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. Handson 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.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.
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:
- Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law._
Locations:
SGP - Singapore - Woodlands
Worker Type:
Employee
Worker Sub-Type:
Regular
Time Type:
Full time
-
Specialist II, Flight Operations
2 months ago
Singapore HQ Scoot Pte Ltd Full timeOn this page you can apply for Job vacancy: Specialist II, Flight Operations (SEP Training)
-
Specialist II, Ground Operations
2 months ago
Singapore HQ Scoot Pte Ltd Full timeOn this page you can apply for Job vacancy: Specialist II, Ground Operations (Ops & Planning BW)
-
Specialist II, Ground Services
2 months ago
Singapore HQ Scoot Pte Ltd Full timeOn this page you can apply for Job vacancy: Specialist II, Ground Services (Warehousing, Stationery & Cargo Services)
-
Specialist II, Flight Operations
3 months ago
Singapore HQ Scoot Pte Ltd Full timeOn this page you can apply for Job vacancy: Specialist II, Flight Operations (SEP Training)
-
Specialist II, Ground Operations
3 months ago
Singapore HQ Scoot Pte Ltd Full timeOn this page you can apply for Job vacancy: Specialist II, Ground Operations (Ops & Planning BW)
-
Network Specialist
2 months ago
Singapore SINGAPORE INSTITUTE OF MANAGEMENT GROUP LIMITED Full timeRoles & ResponsibilitiesThe Network Specialist will plan, design and build the robust, steady and secure corporate network that meet the new business needs defined by SIM's vision. The two key considerations are: High availability inter-networking, Easy accessibility connection. The incumbent will help maintain and operate SIM’s Campus network services...
-
Engineering Validation Specialist II
1 month ago
Singapore Takeda Pharmaceutical Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...
-
Engineering Validation Specialist II
2 weeks ago
Singapore Takeda Pharmaceutical Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...
-
Engineering Validation Specialist II
4 weeks ago
Singapore Takeda Pharmaceutical Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...
-
Application Management Specialist
4 weeks ago
Singapore timesjobs Full time# : Application Management Specialist- **Date:** May 21, 2024- **Location:** Singapore, 01, SG- **Company:** NTT DATA Services## Roles/Responsibilities- Up to 9 years of IT experience & 5 Years in banking/financial services industry. Knowledge on Consumer Loans applications is preferred.- Possess good knowledge on 3 tiers-architecture application to: -...
-
Application Management Specialist
1 month ago
Singapore timesjobs Full time# : Application Management Specialist- **Date:** May 21, 2024- **Location:** Singapore, 01, SG- **Company:** NTT DATA Services## Roles/Responsibilities- Up to 9 years of IT experience & 5 Years in banking/financial services industry. Knowledge on Consumer Loans applications is preferred.- Possess good knowledge on 3 tiers-architecture application to: -...
-
Specialist Marketing Ii
2 weeks ago
Singapore Donaldson Full timeDonaldson is committed to solving the world's most complex filtration challenges. Employing innovation and breakthrough solutions, we are advancing filtration for a cleaner world. We look for the best people to help us succeed, offering opportunities to learn, effect change, and make meaningful contributions at work and in our communities. This is a place...
-
Risk Specialist
2 months ago
Singapore Hays Full timeYour company My client is a top tier investment bank, located in Singapore. They are looking for a Risk Specialist to be part of their integration projects in the region. Your role To perform ex-post control reviews on Global Wealth Management Front Line Staffs in order to assess cases if he/she adhere to the bank policies and requirements Reviews will...
-
Risk Specialist
4 weeks ago
Singapore Hays Full timeYour company My client is a top tier investment bank, located in Singapore. They are looking for a Risk Specialist to be part of their integration projects in the region. Your role To perform ex-post control reviews on Global Wealth Management Front Line Staffs in order to assess cases if he/she adhere to the bank policies and requirements Reviews will...
-
Dir-solutions Specialist
2 weeks ago
Singapore Moody's Full timeRole/Responsibilities:This position sits under the solution specialist team within the sales organization at Moody's Analytics. The solution specialist is a pre-sales role and will work closely with the field sales teams throughout the entire sales cycle by providing deep industry and solution expertise related to Moody's Risk and Finance suite of solutions...
-
Facilities Specialist II
4 weeks ago
Singapore Thermo Fisher Scientific Full timeJob DescriptionWhen you're part of the team at Thermo Fisher Scientific, you'll do important work. Surrounded by collaborative colleagues, you'll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team, and help...
-
Facilities Specialist II
1 month ago
Singapore Thermo Fisher Scientific Full timeJob DescriptionWhen you're part of the team at Thermo Fisher Scientific, you'll do important work. Surrounded by collaborative colleagues, you'll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team, and help...
-
Application Management Specialist
1 month ago
Singapore timesjobs Full time# : Application Management Specialist- Date: May 21, 2024- Location: Singapore, 01, SG- Company: NTT DATA Services## Roles/Responsibilities Up to 9 years of IT experience & 5 Years in banking/financial services industry. Knowledge on Consumer Loans applications is preferred. Possess good knowledge on 3 tiersarchitecture application to:Provide L2 support Be...
-
Application Management Specialist
4 weeks ago
Singapore timesjobs Full time# : Application Management Specialist- Date: May 21, 2024- Location: Singapore, 01, SG- Company: NTT DATA Services## Roles/Responsibilities Up to 9 years of IT experience & 5 Years in banking/financial services industry. Knowledge on Consumer Loans applications is preferred. Possess good knowledge on 3 tiersarchitecture application to:Provide L2 support Be...
-
Senior Quality Operations Specialist
2 weeks ago
Singapore ABBVIE OPERATIONS SINGAPORE PTE. LTD. Full timeRoles & ResponsibilitiesPurposeSenior Quality Operations Specialist must assist site management to oversight the quality system execution on the manufacturing and production areas at all times. Incumbent is required to observe, document, discuss, monitor and trend, and report quality adverse events related to the manufacturing of the product. Incumbent is...
