Quality Co-Ordinator

ICDS RECRUITMENT

West Dublin

Quality Co-ordinator - West Dublin. This position is being offered on a temporary contract basis. In this role you will support the Quality Manager in reviewing, implementing and assessing processes and procedures on site, and in accordance with good manufacturing practice including ISO, BRC and pharmaceutical code of practice standards. You will take responsibility for and manage all administrative tasks within the quality function and provide robust administrative support to the Quality Manager in line with Pharmaceutical Code of Practice. Support Health and Safety initiatives on site and support/lead H&S activities. Provide QMS maintenance support, to include administration, control and review of SOP’s, Work Instructions and controlled documentation. Ensure employees and managers are aware and engaged with changes. Assist with any KPI / performance data on a monthly basis. Manage and maintain the department database ensuring all data is input accurately and timely and reports run and presented to the Quality Manager as appropriate. Review controlled documentation and amend where necessary and ensure sign-off for auditing procedures. Complaint handling: The day to day handling of complaints including investigations, root cause identification, corrective / preventative action implementation, customer responses, internal trend analysis and improvement & dealing with internal issues and non-conformances. Logging non-conformances and preparing and gathering corrective and preventive action (CAPA) statements from key stakeholders to respond to customer complaints. Administration of the calibration and validation systems. Assisting with the management of calibration and frequency and maintenance of calibration records & schedule. Assist the Quality Manager with any validation activities and with the maintenance of validation documentation. Assist with the investigation of any calibration failures. Assist with training and development. Assisting with the development of any training materials and ensure the training matrix is updated and completed. Update training records and ensure all employees have completed key training modules in line with Pharmaceutical Code of Practice. Oversee refresher training is completed following changes to systems of working caused by production or customer specification changes. Assist with audits and continuous improvement. Lead and provide feedback on routine internal audit inspections to ensure site adherence to the quality management system including environmental and health and safety activities in accordance with corporate guidelines and site accreditations to promote best practice. Raising and recording change requests and assisting with tracking, monitoring, and reporting on change progress. Support change control activities. Participate in continuous development and training.

1247 days ago