Quality Compliance Specialist応募 後で応募 求人ID R0007208 掲載日 02/14/2019 Location:Dublin, Ireland
The Quality Compliance Specialist is responsible for the coordination of compliance activities within the compliance group and for varying duties as assigned by the Quality Systems and Compliance Manager.
- Provide oversight and management of key elements of the Quality Management System (QMS) within the compliance group, which includes, Product Complaints and Risk Management. Supporting other elements of the compliance group, including but not limited to, inspection management, metrics/KPIs, Quality council, product quality communications, Regulatory Compliance.
- Administration/co-ordination of Product Quality Complaints.
- 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.
- Preparation of Key Performance Indicators to align with company and global quality objectives.
- 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.
- Participation in the preparation of documentation for regulatory submissions.
- To ensure that the systems with a GMP impact are maintained as per written procedures.
- Assist in 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.
- SME in ICH Q9 Risk Management and/or Product Complaints 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