Senior Quality Excellence (QE) Specialist

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Job Description

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: Senior Quality Excellence (QE) Specialist
Location: Woodlands, Singapore

About the role:

This position is part of the Quality Excellence team responsible for the execution activities related to the deviation and change control quality system to achieve the site objectives and compliance for Takeda Singapore.

How you will contribute:

• Operations:

  • Participate and lead in site investigations relating to Manufacturing/ Engineering/ Validation/ Logistics/ Supply Chain Planning/ Laboratories/ Incoming Material Release and review/approve the investigation report.

  • Ensure timely review and approval of investigation to support release of BDS and raw material.

  • Ensure timely review and approval of change controls to support implementation of changes with exceptions to raw material, computer system validation and new equipment.

  • Facilitate and lead quality process such as daily deviation tracking to provide guidance and drive deviation investigation progress and closures.

  • Review and approve test scripts, protocols associated with deviations and change controls.

  • Ensure timely review and approval of investigation in the event of customer complaints and product recall.

  • Lead as SME in the gap analysis for current SOP/practices with the various subject matter expert to ensure compliance with DM/DPs revision, where gaps are identified, ensure that an implementation/mitigation plan is in place and follow-through to completion.

  • Ensure documents relating to deviations and change controls are properly and timely archived.

• Participate and lead in quality system(s) rollout by ensuring that the elements of the assigned quality system(s) is/ are implemented and maintained at the site according to regulatory, corporate and division requirements for deviation and change control management systems.

• Support the compliance, audit, regulatory and training activities as required, and any other responsibilities as assigned by Supervisor.

• Leadership:

  • Build strong partnerships 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.

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 5 years in pharmaceutical or biotechnology in quality assurance, GMP/GLP compliance, operations or validation, preferably 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.

• Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives.

• Six sigma greenbelt training would be helpful.

Key Skills and Competencies

• 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.

• Be a delegate for QE Supervisor in his/her absence and approve any related documents.

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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