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.
• Good English Literacy and numerical skills.
