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Quality Specialist - Disposition - Dublin 2

Dublin, Ireland

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Quality Specialist - Disposition - Dublin 2

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Job ID SR0052529 Date posted 09/21/2020 Location Dublin, Ireland

Job Summary

  • 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 of material manufactured at contract manufacturing organisations on behalf of Takeda
  • The primary objective of this position is to review executed manufacturing documentation associated with Drug Substance, Drug Product and Finished Drug Product to ensure compliance to products’ authorisations, SOPs and GMP
  • This role works with and enables the Qualified Person to certfify medicinal product prior to releasing these medicines for sale.

ACCOUNTABILITIES

  • Reviewing biological drug substance, drug product and finished drug product  to ensure compliance to Marketing Authorisations, interna; SOPs, GMP and EU/ROW market’s national requirements
  • Enabling material disposition and QP certification of products prior to product release
  • Reviewing executed batch records, deviation investigation reports and change controls for biological drug substances, drug products and finished drug products
  • Maintaining quality records of batch documentation review activitoes
  • Reviewing and approving SOPs / Specifications / Technical Protocols / Reports, including deviation investigation reports in line with company procedures
  • Compiling and reporting appropriate metrics (KPIs) that contributing to quality system oversight
  • Participating in and reviewing audits, audit planning and audit reports
  • Complying with the details of relevant quality agreements with contracted external suppliers, including contract manufacturing and testing organisations and other Takeda internal sites.
  • Preparing for, and participating in quality system reviews with contract manufacturing organisations that assuare ongoing compliance to product authorisations and Good Manufacturing Practice
  • Participating in site audits and inspections
  • Promote adherence to GMP and QA across the Takeda organization

Requirements

  • Bachelor’s degree in chemistry, biology, pharmacy or a related science discipline
  • Minimum of 3 year’s experience working in Quality Assurance supporting the manufacturing of sterile medicinal products or biological medicinal products.
  • Experience with medical devices is desirable   
  • Demonstrated understanding of pharmaceutical quality systems, EU GMP and US Code of Federal Regulations Title 21, Part 210, 211 and 610
  • Experience in parenteral biological manufacturing / QA, 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)
  • Writing and reviewing technical report
  • Experience with product supply chain architecture
  • Experience with adopting Operational Excellence and Continuous Improvement methodologies 

Leadership

While this position does not have direct reports, it is expected that specific leadership behavious are demonstrated:

  • Demonstrable 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

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

  • 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.

ADDITIONAL INFORMATION

  • Fluent in English
  • Proficient in technical report writing and assessment

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.



Job ID SR0052529

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