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Job Description

Quality Assurance Associate

Job Title: Quality Assurance Senior Associate

Location: Grange Castle

About the role:

The Quality Assurance Senior Associate coordinates quality activities within the Quality Assurance group and for responsibilities as assigned by the Quality Assurance Executive for the new the P3 Cell therapy manufacturing facility in Takeda Ireland Ltd, Grange Castle. Some main tasks are outlined below.

Fully onsite work mode.

How you will contribute:

• Manage batch record review
• Manage area clearance record review
• Management and facilitation of investigations as part of the site Deviation Management System, ensuring root cause analysis and assigning of CAPAs.
• Support activities relating to the Quality Management System (QMS), which include; CAPAs, change control, material and service supplier management.
• Assist and co-ordinate the preparation of reports about Annual Product Reviews for products manufactured on site.
• Participate in the on-site GMP Inspection schedule
• Participate in the internal audit schedule.
• Support the Environmental monitoring programme
• Develop SOP & other GMP Controlled Documents.
• Review master records.
• Support activities relating to customer complaints, product returns and product recall
• Support the onsite audit team during external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
• To help develop continuous improvement activities.
• Participate in other projects as directed by the Quality Assurance Executive.
• Support major projects, quality plans and continuous improvement programmes within the Quality department.
• Support and review process simulations (Media Fill).

General Responsibilities:

• Participate in any training plans.
• Promote the corporate values of Takeda-ism within the workplace.
• Foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an necessary part of the business.
• Ensure that Accident Reports / Near Miss Forms are completed promptly after an event.
• Ensure completion of all SOP, reading, training and assessment.
• Other tasks and directed by the relevant Manager or other Officer appointed by the Board of Directors.

What you bring to Takeda:

• Bachelor's degree in chemistry, biology or a related scientific discipline.
• 5 years working within quality in the pharmaceutical industry.
• Experience working in cell culture/ finished product pharmaceuticals/ biologics, including biochemistry, microbiology, quality assurance, quality control, development, and manufacturing areas.
• Experience with quality and cGMP's.
• Be, flexible, organised and a good team player based on departmental and site requirements.
• Work directly with other departments to ensure compliance and productive working relationships.

What Takeda can offer you:

Full Healthcare Cover - includes dependents

Pension Scheme

Attractive Bonus

Subsidised canteen

Parking facilities with electric car charging points

Health & Wellness programmes including onsite flu shots and health screenings

Educational Assistance

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and patient support programmes. Takeda is a patient-focused company to 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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