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.