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Head of Quality Assurance (Operation), Cell Therapy Facility - Grange Castle

応募後で応募 求人ID R0058103 掲載日 01/24/2022 Location:Dublin, Ireland

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Job Description

About the role:

The Head of Quality Assurance (Operations) manages Quality Assurance activities for the Cell Therapy facility at Takeda Ireland Limited Grange Castle and for oversight of routine manufacturing, testing and related activities.

The Head of Quality Assurance will work with other Quality Department personnel as part of the site Quality Department. May assume responsibilities in any of the Quality Department pillars, following our needs.

As with all site personnel, promotes a culture of Regulatory Compliance and Continuous Improvement within the Quality Department and across the Cell Therapy manufacturing plant and the TILGC site.

How you will contribute:

  • Manage the Quality Assurance (Cell Therapy) team, including Qualified Persons.

  • Manage batch record review, batch disposition and material status control activities associated with the Cell Therapy product. (The management of these activities will take place on a shift rota and the future state may be asked to take place 24/7).

  • Support and facilitating, investigations as part of the site Deviation Management System, ensuring root cause analysis and assigning of CAPAs.

  • Manage the Change Control process, ensuring controlled implementation of all GMP related changes.

  • Management of QA oversight of manufacturing, testing and relating activities to ensure ongoing cGMP compliance.

  • Ensure participation of the Quality Assurance (Cell Therapy) team in production and other site meetings.

  • Management Key Performance Indicators for the Cell Therapy Facility to ensure adherence with local and global quality KPIs.

  • Participation in the site Internal Audit programme.

  • Participation in the preparation of, and hosting, external cGMP audits, e.g. from Regulatory Authorities and Global Quality.

  • Manage Inspection readiness and close out of gaps identified in the Inspection readiness assessment and Site Inspection Success Rating (SSIR).

  • Participation in the preparation of documentation for regulatory submission and participation in regulatory affairs discussions.

  • Take a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement.

  • Implement efficiency improvements in Quality Dept and participating in site projects and Global Quality plans.

  • Communication and liaison with other TILGC departments on Quality issues, providing guidance to others.

  • Training, discipline and appraisal of Quality Assurance staff.

  • Preparation, Input to submission and the management of Quality Budget

  • Reporting to the Head of Quality for Cell Therapy.

General responsibilities:

  • Participate in any cross functional training plans.

  • Mentor the QA team

  • Guide and promote the corporate values of Takeda-ism within the workplace.

  • Foster, in cooperation with other staff, an ethos and culture of safety awareness where safety is accepted as an important part of the business. Ensure that Accident Reports / Near Miss Forms are completed on time after an event.

  • Ensure completion of all SOP, reading, training and assessment.

  • Other tasks directed by the relevant Manager or other Officer appointed by the Board of Directors.

What you bring to Takeda:

EDUCATIONAL REQUIREMENTS:

  • Primary Degree in Scientific discipline

  • Qualified Person status (desirable

RELEVANTEXPERIENCE:

  • More than 7 years' experience working an aseptic environment in the pharmaceutical industry in a Biologics company

  • Minimum of 3 years' experience in a people management role

SKILLS:

  • Excellent knowledge of Good Manufacturing Practice for aseptic pharmaceutical manufacture as described in current FDA & EMEA regulations.

  • Experience managing and motivating a team.

  • Project management skills.

What Takeda can offer you:

  • Excellent conditions and benefits

  • Genuine career progression and development

  • Opportunity to work with an excellent leader in the pharmaceutical sector

  • Professional development opportunities

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.

Locations

Grange Castle, Ireland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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