Ref No: AM17256
Co. Dublin, Ireland
Quality Co-ordinator - West Dublin.
This position is being offered on a temporary contract basis initially, with the possibility of permanence.
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