- Job Description
The Quality Systems Executive is responsible for the coordination of key Quality Systems related activities within the Quality Systems group and for varying duties as assigned by the Quality Systems and Compliance Manager. Some key tasks and responsibilities are outlined below.
- Supervisory duties for Quality Systems personnel within the Quality Systems group.
- Provide oversight and management of elements of the Quality Management System (QMS), which includes, but not limited to, change control, deviations, CAPAS, documentation, supplier quality management and GMP training.
- Provide oversight and management of the supplier approval programme and the external audit schedule.
- Participate in the internal audit schedule.
- Administration/co-ordination of risk assessments.
- Develop and write SOP & Controlled Documents.
- Be a key member of the onsite audit team during external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
- Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
- Assist and co-ordinate the preparation of reports in relation to Annual Product Reviews for all products manufactured on site.
- To ensure that the systems with a GMP impact are maintained as per written procedures.
- Assist and co-ordinate implementation of global standards and procedures into the site Quality Systems.
- To actively support the development/implementation and continuous improvement of the Quality Management Systems.
- To be cross-trained in multiple quality systems.
- Participate in other projects as directed by the Quality Systems & Compliance Manager.
- 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.
- Bachelor’s degree in chemistry, biology or a related scientific discipline.
- A minimum of 10 years working within quality in the pharmaceutical industry.
- A minimum of 5 years’ experience in a people management role is desirable.
- Experience working in finished product pharmaceuticals/biologics, including analytical chemistry, quality assurance, quality control, development, and/or manufacturing areas.
- Thorough understanding of quality systems 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.
Grange Castle, Ireland