Quality Assurance Senior Associate

Job Description

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Job Description

Location: Grange Castle

About the role:

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

Fully onsite work mode.

How you will contribute:

• Management and execution of batch record review
• Management and execution of area clearance record review
• Management and facilitation of investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
• Support activities relating to the Quality Management System (QMS), which include, but not limited to; CAPAs, change control, material and service supplier management.
• Assist and co-ordinate the preparation of reports in relation to Annual Product Reviews for products manufactured on site.
• Responsible for compiling batch packs and associated documentation for the release of Batches to market
• Ensuring all records relating to batch manufacture are reviewed and approved as appropriate prior to product certification and release by the Qualified Person (QP).
• 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 of 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 actively support the development/implementation of continuous improvement activities.
• Participate in other projects as directed by the Quality Assurance Executive.
• Actively support major projects, quality initiatives and continuous improvement programmes within the Quality department and in other functional areas.
• Support and review Aseptic Process Simulations.

General Responsibilities:

• Participate fully in any cross functional training initiatives.
• Drive and promote the corporate values of Takeda-ism within the workplace.
• Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
• Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
• Ensure timely completion of all SOP, reading, training and assessment.
• Other duties as required 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.
• A minimum of 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/or manufacturing areas.
• Thorough understanding of quality and cGMP's.
• Excellent verbal and written communication skills.
• Be self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements.
• Work directly with other key 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 programs 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 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.

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