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External Biologics Associate Director Disposition and Qualified Person (Hybrid)

Location
Dublin, County Dublin
Job Type
Permanent
Posted
21 Sep 2022

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Job Description

About the role :

  • This individual will work in the Disposition Team of the External Biologics Quality Organization at Takeda and will be based in Dublin. This team is responsible for biological material disposition, including QP certification, of material manufactured at contract manufacturing organisations on behalf of Takeda

  • Review and disposition of external manufactured Drug Substance, Drug Product and QP certification of Finished Drug Product to products' authorisations and GMP.

How you will contribute:

Accountabilities

  • QP certification of biological drug substance, drug product and finished drug product in compliance with Marketing Authorisations, GMP and EU/ROW market's national requirements

  • Qualified Person status achieved with min 3-5 years of relevant work experience acting as Qualified Person, named on a Manufacturing Authorisation

  • Complying with Annex 16, Certification by a Qualified Person and Batch Release, to EudraLex, Volume 4 - Good Manufacturing Practice (GMP) guidelines

  • Performing material disposition.

  • Reviewing and dispositioning executed batch records, deviation investigation reports and change controls for biological drug substances, drug products and finished drug products

  • Maintaining the QP batch register.

  • Reviewing and approval of SOP / Specification / Technical Protocols / Reports, including deviation investigation reports in line with company procedures.

  • Participating in Takeda Global Incident Management processes ensuring appropriate incident escalation and reporting defects to supervisory health authorities where appropriate.

  • Participating in qualification of CMO's and contact laboratories.

  • Participating the the Global Quality Council as is periodically convened.

  • Reviewing and approving product quality reviews.

  • Participating and reviewing product complaint investigations.

  • Compiling and reporting appropriate metrics (KPIs) that contribute to quality system oversight.

  • Participating in and reviewing audits, audit planning and audit reports.

  • Participating in technology transfer, process scale-up, and process improvement projects.

  • Complying with the details of relevant quality agreements with contracted external suppliers, including contract manufacturing and testing organisatuions and other Takeda internal sites.

  • Preparing for, and participating in, quality system reviews with contract manufacturing organisations that assure ongoing compliance to product authorisations and Good Manufacturing Practice

  • Participating in site audits and inspections.

  • Promoting adherence to GMP and QA across the Takeda organization.

Dimensions and Aspects

Technical/Functional (Line) Expertise

  • Eligible to work as a Qualified Person meeting the requirements of Article 49 of Directive 2001/83/EC of the European Parliament, as amended

  • Bachelor's degree in chemistry, biology, pharmacy or a related discipline

  • Thorough understanding of quality systems, EU GMP and GDP and US Code of Federal Regulations Title 21, Part 210, 211 and 610

  • Quality experience in parenteral biological manufacturing particularly in the requirements for manufacture of sterile medicinal products (EU GMP Volume 4, Annex 1) and manufacture of biological active substances and products (EU GMP Volume 4, Annex 2).

  • Experience with collaborative working with Contract Manufacturing Organisations (CMO).

  • Technical report writing and reviewing.

  • Experience with product supply chain architecture.

  • Experience with leading and adopting Operational Excellence and Continuous Improvement methodologies.

Leadership

  • Demonstratable practice of influencing skills and facilitating compliance to GMP

  • Excellent written communication skills

  • Critical thinking/ evaluation of process problems

  • Data trending and evaluation

  • Strong collaborative work ethic

  • Ability to work independently

Decision-making and Autonomy

  • Decision maker for batch disposition / manufacturing / analytical testing / out-of-specification (OOS) / packaging deviation investigations, recognising impact of decisions

Interaction

Internal

  • Quality Leadership Team

  • External Quality Team

  • Supply Chain & Customer Services

  • External Supply and Manufacturing

  • Regulatory Affairs

  • Pharmaceutical and Analytical Development

  • Process Development

External

  • Regulatory Authorities

  • Customers' Regulatory Affairs representatives

  • Contract Manufacturers

  • Contract Distributors

  • Contract Laboratories

Innovation

  • Contribution of thought, experience, background, and skills in the areas of GMP and compliance, and enhancing overall organizational compliance.

Complexity

  • Drives coordination and execution of batch review and disposition processes and projects. Facilitates and aligns activities across teams to ensure compliance.

  • Escalates issues related to MA/GMP non-compliances.

Additional Information

  • Fluent in English.

  • Proficient in technical report writing and assessment.

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

IRL - Dublin - Baggot Street

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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Details

  • Job Reference: 717421240-2
  • Date Posted: 21 September 2022
  • Recruiter: Takeda Pharmaceutical
    Takeda Pharmaceutical
  • Location: Dublin, County Dublin
  • Salary: On Application
  • Sector: Manufacturing Operations
  • Job Type: Permanent