Quality Compliance Specialist

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Job Description

Company Profile:

Takedas 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 companys Biologics Operating Unit network the site is Takedas only biologics drug substance manufacturing facility in Asia. The facility has two buildings including manufacturing suites and laboratories as well as Takedas first positive energy building certified by Singapores Building and Construction Authoritys Green Mark scheme in 2022.

Location: Woodlands Singapore

About the role:

This position is responsible for site quality compliance governance and product quality and compliance communications to achieve the site objectives for Takeda Singapore.

How you will contribute

1. Inspection and Audit Management

Support to host and manage regulatory inspection and communications.

Support and ensure the site is inspection ready at all times.

Lead and support the site inspection readiness activities.

Lead Auditor to lead the self inspection program and plan for self inspection schedule.

To perform supplier qualification which include supplier audit.

2. Site Quality Compliance Governance

Participate and lead 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 requirement for Quality Council and Quality Risk Register.

Participate in any corporate/division alignment meetings for information learning & sharing and alignment of best practices.

Responsible for reporting site KPIs and matrix to the site management.

Host and manage monthly Quality Councils meeting.

Oversight and manage site Quality Risk Management.

3. Product Quality and Compliance communications

Participate and lead 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 requirement for Product Recall Quality.

Ensure timely investigation and report for customer complaints and product recall.

Coordinate and report product quality issues to health authorities via quality incident management process.

What you bring to Takeda:

Education and Experience Requirements

University degree in Biotechnology Chemistry Pharmacy Science Engineering or equivalent.

At least 5-7 years of experience in Pharmaceutical or related manufacturing environment.

Demonstrated ability to collaborate with cross functions or cross sites to achieve objective.

Key Skills and Competencies

An ability to interact and communicate with all types of personalities in an effective and diplomatic manner.

Ability to create and mediate common understanding and communicate expectations on compliance.

Presentation skills for audit training and Senior Management.

Substantial knowledge in regulatory requirements such as Eudralex 21CFT ICH etc.

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

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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