Quality Excellence - Singapore - ARIAD

ARIAD

Verified Company

Singapore

3 weeks ago

Posted by:

Wei Jie

beBee Recruiter

Description

At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization.

It's reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network.

When you're a part of our team, you'll do meaningful work that makes an impact on the lives of patients.

Learn more about us and explore the opportunities to build a remarkable career.

Job ID R0122561
Date posted 05/08/2024
Location Singapore, SingaporeTakeda'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 Excellence (QE) Specialist II

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 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 quality processes 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.
Ensure documents relating to deviations and change controls are properly and timely archived.
Participate 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.
Support the compliance, audit, regulatory and training activities as required, and any other responsibilities as assigned by Supervisor.
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

A minimum experience of 3 years in the 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 the quality systems.
Equip with good knowledge in the various regulatory requirements.
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, disabilit