Quality Assurance Officer

Job description

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, NI D 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 compliance with 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. • Good English Literacy and numerical skills.