QA Specialist Disposition - Contract - Dublin 2

QA Specialist Disposition - Contract - Dublin 2

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Quality Specialist - Disposition- contract role at our Dublin office.

Here, you will be a vital contributor to our inspiring, bold mission.

As a , you will be empowered to work in coordination with , In this role, you will contribute to Takeda’s mission. A typical day will include:

QA Specialist Disposition - Fixed Term Contract

OBJECTIVES/PURPOSE

• 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 certify medicinal product prior to releasing these medicines for sale.

ACCOUNTABILITIES

• Review of biological drug substance, drug product and finished drug product in compliance with Marketing Authorisations, 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 activities
• 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 assure ongoing compliance to product authorisations and Good Manufacturing Practice
• Participate in site audits and inspections
• Promote adherence to GMP and QA across the Takeda organization

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• 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:

• 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

• Enabling batch disposition. Participating and influencing 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

WHAT TAKEDA CAN OFFER YOU

• Excellent conditions & benefits including generous holidays
• Genuine career progression and development
• Opportunity to work with a world class leader in the pharmaceutical sector
• Ideally located in Dublin 2.

At Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global 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

Discover more at takedajobs.com

Locations

IRL - Dublin - Baggot Street

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time

Job ID R0027964