Senior Quality Systems 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 Systems Specialist
Location: Woodlands, Singapore

About the role:

This position is part of the Quality Systems team responsible for implementation and maintenance of the various Quality Systems and to lead the supplier management and material management (includes material qualification) as well as validation related activities which includes Data Integrity at site.

How you will contribute:

To lead the Supplier Quality Management Process (Supplier Complaints, Supplier Notification of Change, Quality Agreement, Supplier Monitoring and SMS Trackwise System) and service providers to ensure product quality and regulatory compliance.

To lead the supplier investigation action report and to provide consistent approach aligned with Global Supplier Quality.

To lead the Material Management program (Specification, Implementation which includes Material Qualification, Impact Assessment, Complaints and support activities in regulatory, production). To lead the creation and implementation of specification as well as managing issues related to materials.

To provide quality oversight on Material Qualification such as review and approval of protocols, reports, procedures and other related documents to ensure compliance to internal procedures and regulatory requirements.

To provide quality oversight on the discrepancy related to qualification/validation protocols in order to guarantee documentation of the incidents and identification of corrective actions.

Support the quality system team to establish, disseminate and monitor the implementation of appropriate quality systems and compliance standards for the site according to regulatory and global requirements.

Change control management

Documentation management

Investigation program management

Corrective and Preventive action system

Annual product review management

IT Systems Quality

Support on the oversight of the Integration Program. To support on the gap analysis for local procedure with collaboration with subject matter experts in compliance with global procedure and ensure that an implementation is in place and track for completion. Assessment on internal procedures and external regulations.

Collaboration and participations in projects as Quality Representative for Quality Systems.

Participation in internal and external audit as required.

Participate in the evaluation of Plant Change Management (PCM) requests and provide support in the review of the associated risk assessment.

Provide material/supplier related impact assessments for change control.

Support on the oversight of the Integration Program. To support on the gap analysis for local procedure with collaboration with subject matter experts in compliance with global procedure and ensure that an implementation is in place and track for completion. Assessment on internal procedures and external regulations.

Collaboration and participations in projects as Quality Representative for Quality Systems.

Participation in internal and external audit as required.

Participate in the evaluation of Plant Change Management (PCM) requests and provide support in the review of the associated risk assessment.

Provide material/supplier related impact assessments for change control.

Ensuring the information contained in approved qualification/validation document(s) is understandable and defendable during inspection.

 Participate in multisite initiatives to ensure harmonization of Quality Systems, Supplier/Material Management and qualification/validation related activities between the plants.

 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

The candidate should have at least a degree in pharmaceutical sciences, life sciences, biology,’ biotechnology chemistry, chemical engineering, or a related discipline. Additional certification and trainings such as auditor training or QP training will be advantageous.

A minimum experience of 5 years in the pharmaceutical or biotechnology in quality, GMP/GLP compliance, operations or validation, ideally in a multinational company, supplier quality management, material management.

Understanding of FDA/EU cGMP and ICH guidelines, any exposure/experience to the international regulatory network/audits will be advantages.

Key Skills and Competencies

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

Able to logically solve problems in order to find timely solutions.

Ability to handle complex validation discrepancy, supplier and material complaints

Good Verbal and written communication.

Critical thinking and demonstrated problem solving skills.

Deep knowledge of regulations and a thorough understanding of ICH guidelines and the various validation guides such as PDA Technical guides, ISPE GAMP guides etc.

Ability to lead / support CAPA investigation

Ability to provide coaching to others

Communication skills and organization skills.

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.

Locations

SGP - Singapore - Woodlands

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time