Quality Operations Specialist I – 12 months contract

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Job Description

Company Profile:

Takeda's Singapore biologics manufacturing facility focuses on manufacturing potentially life-saving medicines for patients suffering from rare blood disorders such as Hemophilia A and B. As part of the company’s Biologics Operating Unit network, the site is Takeda’s only biologics drug substance manufacturing facility in Asia. The facility has two buildings, including manufacturing suites and laboratories, as well as Takeda’s first positive energy building certified by Singapore’s Building and Construction Authority’s Green Mark scheme in 2022.

Job Title: Quality Operations Specialist I – 12 months contract
Location: Woodlands, Singapore

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

1. Member of the QO team in ensuring quality oversight at the manufacturing suite.
2. Partner with the manufacturing team in the implementation and adherence to the various quality systems and GMP requirements.
3. Participate in meetings with the manufacturing team for information learning/sharing and alignment of best practices.
4. Support compliance, regulatory inspections, training activities, and any other responsibilities assigned by the supervisor.

QO Operations

1. Revise and participate in the development and writing of procedures pertaining to QO operations.
2. Support the manufacturing team with the development and writing of process standard operating procedures and master batch records ensuring compliance with current good documentation practices and applicable global procedures and regulatory requirements.
3. Take ownership of investigations relating to quality operations.
4. Review executed manufacturing batch records (MBR) and approve revisions.
5. Participate as SME in gap analysis for current SOP/practices with various subject matter experts to ensure compliance with global procedures, ensuring implementation/mitigation plans are in place.
6. Participate in cross-functional investigations where assigned.
7. Support the manufacturing team with quality interpretation, queries, and issues.

Other responsibilities (if assigned):

1. Render timely support for the release of Bulk Drug Substances (BDS) and resolution of release matters.
2. Provide QO-related impact assessments for change controls and take ownership of change controls relating to quality operations.
3. Participate in routine GMP walk-throughs with the manufacturing team.
4. Participate in process improvements/studies with the manufacturing team and draft test scripts/protocols.
5. Perform timely archival of QO documents.
6. Manage cell bank and BDS reference samples.

Leadership:

1. Build strong partnerships with all other departments to ensure open communication and acceptance.

Others:

1. Responsibility to adhere to any applicable EHS requirements.
2. Commitment to a fair and respectful relationship with others and behavior in accordance with Takeda’s Code of Conduct.
3. Any other duties as assigned by the supervisor.

What you bring to Takeda:

Education and Experience Requirements:

1. The candidate should have at least a degree in pharmaceutical sciences, life sciences, biology, biotechnology, chemistry, chemical engineering, or a related discipline.
2. Preferably a minimum experience of 0 - 2 years in the pharmaceutical or biotechnology industry 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) and downstream (e.g., purification, column packing) will be an advantage.
3. Understanding of FDA/EU and ICH guidelines; any exposure/experience to the international regulatory network will be an advantage.

Key Skills and Competencies:

1. Good knowledge of quality systems.
2. Good knowledge of various regulatory requirements.
3. Product release knowledge is preferred.
4. Able to logically solve problems to find timely solutions.
5. Able to interact and communicate with all types of personalities effectively and diplomatically.

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:

Takeda is proud of 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

Fixed Term (Fixed Term)

Time Type

Full time