Qualified Person (Ninlaro)Apply Now Email Me Job ID R0003212 Date posted 07/12/2018 Location:Dublin, Ireland
The Quality Person/Quality Assurance Executive (Ninlaro) is responsible for managing the Quality Assurance team associated with production of oral solid dosage product in the P2 (Ninlaro) production facility at Takeda Ireland Limited Grange Castle (TILGC). In particular, the Quality Assurance Executive (Ninlaro) will assume the role of Lead Qualified Person for the release of Ninlaro product in accordance with EU Directive 2001/83/EC.
In accordance with business needs, the Quality Assurance Executive (Ninlaro) may assume responsibilities in any other work area of the TILGC Quality Department.
As with all site personnel, the Quality Assurance Executive (Ninlaro) 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 Executive (Ninlaro) include the following:
- Management of the Quality Assurance team in the Ninlaro production facility.
- Management of batch disposition and material status control activities associated with Ninlaro, acting as a site Qualified Person.
- 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 Ninlaro 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 Quality Assurance Manager 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 a scientific discipline
- Must meet the educational requirements of a Qualified Person as per EU Directive 2001/83/EC.
- Minimum of 5 years’ experience in the pharmaceutical industry in a Quality role.
- Minimum of 2 years’ experience working as a Qualified Person.
- Experience of oral solid dosage manufacture.
SKILLS / COMPETENCIES:
- Excellent knowledge of Good Manufacturing Practice as described in current FDA & EMEA regulations for oral solid dosage pharmaceutical manufacture.
- High level of initiative.
- Excellent verbal and written communication skills.
- Strong project management and organisational skills.
- Ability to adapt to changing priorities.
- People management experience is desirable but not essential.
Grange Castle, Ireland