Quality Operations Specialist II

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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 II
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

• 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

Leadership

• Build strong partnership with all other departments to ensure open communications and acceptance.

Others:

•  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

• 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.

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 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.

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