Quality Assurance Manager, Cell Therapy応募 後で応募 求人ID R0007843 掲載日 03/21/2019 Location:Dublin, Ireland
The Quality Assurance Manager (Cell Therapy) is responsible for managing Quality Assurance activities for the Cell Therapy facility at Takeda Ireland Limited Grange Castle.
The Quality Assurance Manager (Cell Therapy) will work closely with other Quality Department personnel as part of the site Quality Department. The Quality Assurance Manager (Cell Therapy) may assume responsibilities in any of the Quality Department pillars, in accordance with business needs.
As with all site personnel, the Quality Assurance Manager (Cell Therapy) is responsible for promoting a culture of Regulatory Compliance and Continuous Improvement within the Quality Department and across the TILGC site.
The responsibilities of the Quality Assurance Manager (Cell Therapy) include the following:
- Management of the Quality Assurance (Cell Therapy) team, including Qualified Persons.
- Management of batch record review, batch disposition and material status control activities associated with the Cell Therapy product. These activities will take place 24/7.
- Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
- Management of 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.
- Ensuring effective participation of the Quality Assurance ((Cell Therapy)) team in production and other site meetings.
- Implementation of Key Performance Indicators within the Quality Assurance area to align with company and global quality objectives.
- 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.
- Participation in the preparation of documentation for regulatory submission and participation in regulatory affairs discussions.
- Taking a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement.
- Implementing efficiency improvements in Quality Dept on a continuous basis and participating in site projects and initiatives.
- Communication and liaison with other TILGC departments on Quality issues (as required), providing guidance and support to others.
- Motivation, training, discipline and appraisal of Quality Assurance staff.
- Acting as a designee to the Head of Quality for Cell Therapy as required.
- 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 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.
- Primary Degree in Scientific discipline
- Qualified Person status is highly desirable but not essential
- More than 7 years’ experience working an aseptic environment in the pharmaceutical industry, preferably in a Biologics company
- Minimum of 3 years’ experience in a people management role
SKILLS / COMPETENCIES:
- Excellent knowledge of Good Manufacturing Practice for aseptic pharmaceutical manufacture as described in current FDA & EMEA regulations.
- Demonstrable experience managing, motivating and leading a team.
- A high level of initiative is required
- Excellent verbal and written communication skills are essential.
- Strong project management and organisational skills.
- Ability to adapt to changing priorities
Grange Castle, Ireland