**Position** **Summary:** The role of the Quality Assurance Officer - QMS, Products is to: - Perform QA activities to support the quality system and ensure all activities meet GMP guidelines, NID regulations and ISO Standards. - Carry out sampling and testing in accordance with the Quality System and GNIP regulations. A tertiary qualification in a relevant scientific discipline or equivalent, with a minimum of 1-year experience in a GB P/ ISO certified environment. **Key Responsibilities / Authorities:** OC Sampling & Testing: - The Quality Assurance Officer will carry out sampling and testing according to standard operating procedures. - Ensure all activities meet GMP and ISO guidelines as specified by FCC quality system and training. - Ensure all activities are carried out in a safe manner and according to Workplace Health and Safety regulations. - Sampling and testing of packaging materials, raw materials, intermediate products and finished products to verify they meet specifications. - Assist production staff in relation to any information or guidance required for quality issues in conjunction with Laboratory management. - Ensure compliance for laboratory activities undertaken within FMC guidelines. - Send samples to approved contract testing laboratories. - Preparation of solutions and reference standards. - Approve all chemical reagents before use. - Check the calibration status of all laboratory equipment before use. Ensure that all laboratory equipment is calibrated as per the calibration schedule. - Ensure laboratory data is recorded on the appropriate registers. - Perform stability testing on haemodialysis solutions as per the stability studies schedule. - Maintain orderly storage of retention samples. - Notify the QA Manager / Lab Supervisor of any discrepancies or out of specification results inn mediately. - Only approve products for further processing that test within specification. - Ensure the lab supervisor is advised of any low stock materials used in the laboratory including chemicals and glassware.



- Ensure that all data is recorded on the correct forms in real time. - Ensure that changes to any recorded data are only made in the correct manner and sig ned and dated as per training. - Assist in internal audits for compliance with FMC quality systems. - Carry out other projects as directed by the Quality Assurance Manager/ Laboratory Supervisor. Ouality Management Systems: Assist in the developmentand maintenanceof QualitySystems and provide support and guidanceto ensure compliancewith applicablestandards. - Assist with Non-conformance and Deviation Management. Ensure corrective / preventative actions are taken and are effectively implemented. - Review and maintain specifications, standard operating procedures and other quality documents. - Work closely with other departments to ensure staffs are working in compliance with internal policies and procedures. - Assist with the development and implementation of QA process improvements. - Ensure all activities are carried out in a safe manner and according to Work, Health and Safety regulations. - Assist in internal audits for compliance with FMC quality systems. - Assist in introduction of global documents, policies for effective implementation on site - Carry out other projects as directed by the Sr Quality Assurance Manager. Business Expansion / Product Introduction - Assist Sr QA associate in establishing quality plans and related activities for Smithfield. - Assist Sr QA associate in managing site QMS effectively, ensure ISO and EU MDR certification is maintained during project roll overs. EnsureQA/productcompliancemaintainedfor Smithfieldproductprofile (both Smartbags and ProcedurePacks) **Description of Qualification, Key Skills, Personal Attributes:** - A tertiary qualification in a relevant scientific discipline or equivalent. - Minimum 1-year experience in a GMP, Medical Devices and/or ISO certified environment. - Excellent written and verbal communication skills. - Ability to manage a hig h throughput of work while meeting quality and business requirements and deadlines by having excellent organisational skills. - Computer literacy. - Positive English Literacy and numerical skills.

📌 Quality Assurance Officer (Smithfield)
🏢 Fresenius Medical Care
📍 Smithfield