Head of Quality Assurance
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The Head of Quality Assurance is responsible for managing the QA area at Takeda Ireland Limited Grange Castle and for oversight of routine manufacturing, testing and related activities. Manufactured products include API, oral solid dosage product and biologics.
The Head of Quality Assurance will work closely with other Quality Department personnel as part of the site Quality Department. The Head of Quality Assurance may assume responsibilities in any of the Quality Department pillars, in accordance with business needs.
As with all site personnel, the Head of Quality Assurance 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 Head of Quality Assurance include the following:
- Management of the Quality Assurance team, including Qualified Persons.
- Management of all batch disposition and material status control activities.
- Management of review of Batch Manufacturing Records (BMRs).
- 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 routine manufacturing, testing and relating activities to ensure ongoing cGMP compliance.
- Ensuring effective participation of the Quality Assurance 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 Site Quality Head 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
- Minimum of 10 years experience in the pharmaceutical industry in a Quality role.
- Minimum of 3 years’ experience in a people management role.
SKILLS / COMPETENCIES:
- Excellent knowledge of Good Manufacturing Practice as described in current FDA & EMEA regulations for pharmaceutical manufacture.
- 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
- Qualified Person status is highly desirable but not essential
- Experience of oral solid dosage manufacture and sterile manufacture is desirable but not essential
LocationsGrange Castle, Ireland
Time TypeFull time
Job ID R0024666