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Job Description

About the Role:

Supports cGMP activities for products in late phase clinical programs and commercial launch, including manufacturing, testing, packaging and shipment of all materials, to ensure compliance with Takeda QMS, cGMP and global regulatory requirements.

Works as part of the Vaccines External Quality Team, Asia with focus in Quality Assurance systems/process execution related to product specific late phase clinical programs, product technology transfer and commercial activities, including but not limited to, batch assessment & disposition, documentation & data control, change control, investigations, inspection preparedness, life cycle management activities.

Assures consistency in achieving product quality and compliance across multiple Contract Manufacturing Organizations (CMO)s and global markets.

How you will contribute:

Responsible for day-to-day interactions with contract facilities (CMOs, CTLs, and/or CSPs):

• Conducts/supports investigations on Good Manufacturing Practice (GMP) related issues or observations associated with audits, batch records and complaints.

• Reviews and approves (where applicable) manufacturing and testing deviations and investigations into out-of-specification results.

• Supports timely execution and completeness of change management at interface with CMOs (incl. supplier notification of changes) and of internal Takeda change management

• Reviews and approves batch production records and test records.

• Reviews and approves validation documentations

• Reviews and approves shipment or material transfer request 

• Performs interim batch assessment (Diluent, DS, DP, FDP) in preparation for QP release where applicable

Ensures collaboration with and provides guidance to external manufacturing, project management, supply chain, Manufacturing Science and Technology and CMOs to ensure Q-Systems compliance and manages compliant and timely closure of deviations, CAPA, change controls and interim batch assessment as applicable.

Executes regular Person in Plant QA oversight and leverages insights to ensure compliance and drive performance and continuous improvement.

Manages document life cycle (incl. reviews, approval, make-effective and retirement) of GMP   related documents, such as master batch records, risk assessments, etc. according to Takeda QMS requirement.

In early stage of project, support, review and approve development, technology reports where applicable. Review of submission document ensuring data integrity to source data.

Provides guidance for technology transfer and validation of manufacturing processes, ensures compliance to Q-systems and regulatory guidances; reviews and approves applicable  documents.

Supports regulatory or Takeda global audits (including product specific inspections at CMOs), VBU Self-Assessment activities and risk mitigation activities identified in Risk Register.

Maintains culture of teamwork, cooperation and continuous improvement.

Other duties as assigned.

Why you bring to Takeda:

• Minimum of Bachelor’s Degree in Pharmacy, Chemistry, Microbiology, or Life Sciences, or equivalent scientific discipline.

• Minimum of 5 years of experience in quality or regulatory compliance within the pharmaceuticals, biologics, or other related industry(ies).

• Experience of cGMPs, ICH and other relevant regulations. A broad based knowledge of domestic, and general knowledge of international regulations associated with manufacturing, testing and packaging.

• Excellent communication skills both oral and written.

• Experience with supporting product inspections from global Regulatory Authorities.

• Effectively represent Quality Assurance, both internally and externally.

• Experience in routine office software packages and specialized software applications as appropriate.

• Exhibit and promote Takeda Core Competencies.

Licenses /Certifications

• N/A

Physical Demands:

Manual dexterity required to operate office equipment (i.e. computers, phones, etc.)

Travel Requirements:

• Some international travel may be required. Approximately 5 – 20%.

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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