Quality Assurance Officer

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.