Takeda Pharmaceuticals Validation Specialist in Dublin, Ireland

Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Validation Specialist in our Grange Castle API Manufacturing Site in Dublin 22.

Takeda is a global pharmaceutical leader with more than 30,000 professionals working together across more than 70 countries. We have an unwavering dedication to put people first and we live our values of Takeda-ism: Integrity, Fairness, Honesty, and Perseverance. We are united by our more than 230-year legacy of research-based pharmaceuticals and our mission to strive toward Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

The Validation Specialist is responsible for the coordination of all validation activities on site ensuring compliance with current regulatory requirements. The Validation Specialist will have specific and varying duties as assigned by the Quality Director. Some key tasks and responsibilities are outlined below:

•Provide expertise in the area of validation at Takeda Ireland Ltd Grange Castle (TILGC), ensuring compliance with current industry regulations, guidelines and trends.

• Coordinate execution of all validation activities at TILGC including the following:

  • Qualification of premises, equipment and utilities.

  • Computer system qualification.

  • Laboratory equipment validation.

  • Process validation.

  • Cleaning validation.

• Prepare and maintain policies and SOPs associated with validation.

• Prepare and maintain TILGC validation master plans, protocols and reports

• Review validation documents prepared by other personnel as required.

•Execute validation protocols when required, including preparation of, and review of, deviations associated with validation activities.

• Participate in cross-functional project teams as the validation representative.

• Coordinate the TILGC periodic review and revalidation programme.

• Ensure that all TIGC change controls are assessed for impact on validation.

• Participate in TILGC Continuous Improvement programmes.

• Participate in other projects as directed by the Quality Director.

REQUIRED QUALIFICATIONS:

  • Primary degree in a scientific discipline.

  • A minimum of 5 years’ experience in a validation role in the pharmaceutical industry.

  • Computer systems validation experience is required.

  • Excellent verbal and written communication skills

  • Be self-motivated, flexible, organized and a good team player with the ability to prioritize own work based on departmental and site requirements.

What Takeda Can Offer YouTo further support and inspire our employees, our benefits include: Talent & Development Programme, Flexibility, Occupational Health & Wellness Programme, Company Events, Health Insurance, Pension, Paid Maternity/Paternity Leave, Educational Assistance Programme, Performance Related Bonus, Zero Absence Award, Onsite Parking, and Onsite Canteen

Empowering Our People to Shine. Learn more at takedajobs.com.

Takeda Ireland Limited is an Equal Opportunities Employer

*LI-PD2-EUR

Job: *Regulatory Affairs

Title: Validation Specialist

Location: IE-Dublin-Grange Castle

Requisition ID: 1702596