Quality Assurance Officer

PositionSummary:

The roleofthe Quality Assurance Officer - QMS, Products is to:

- Perform QA activities to support the quality system and ensure all activities meetGMPguidelines,NIDregulations andISOStandards.

- Carryoutsampling and testing in accordance with the Quality System and GNIP regulations.

A tertiary qualification inarelevant scientific disciplineorequivalent,withaminimumof1-yearexperiencein aGBP/ISO certified environment.

Key Responsibilities / Authorities:

OC Sampling&Testing:

•    The Quality AssuranceOfficerwill carry out samplingandtesting accordingtostandard operating procedures.

•    Ensureall activities meet GMP and ISO guidelines as specifiedbyFCC quality system and training.

•     Ensure all activitiesarecarriedout ina 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 staffinrelation toanyinformation or guidance required for quality issuesinconjunction with Laboratory management.

•    Ensure compliance for laboratory activities undertaken within FMC guidelines.

•    Send samplestoapproved contract testing laboratories.

•    Preparationofsolutionsandreference standards.

•    Approve all chemical reagents before use.

•    Checkthe calibration status of all laboratory equipment before use. Ensure that all laboratory equipment is calibrated asperthe calibration schedule.

•    Ensure laboratory data is recordedonthe appropriate registers.

•    Perform stability testing on haemodialysis solutions as per the stability studies schedule.

•    Maintain orderly storage of retention samples.

•    Notify the QA Manager /LabSupervisorofanydiscrepancies or out of specification results

inn mediately.

•    Only approve products for further processing thattestwithin specification.

•    Ensurethelab supervisor is advisedofanylow stock materials usedinthe laboratory including chemicals and glassware.

•    Ensure that all dataisrecordedonthe correctformsin real time.

•    Ensure that changes toanyrecorded dataareonlymadein the correct manner and signedand datedasper training.

•     Assist in internal auditsforcompliance 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 supportandguidanceto ensure compliancewithapplicablestandards.
•     AssistwithNon-conformanceandDeviation Management. Ensure corrective / preventative

actions are taken and are effectively implemented.

•    Reviewandmaintain specifications, standard operating procedures and other quality documents.

•     Work closely with other departmentstoensure staffs are working in compliance with internal policiesandprocedures.

•     Assist with the development and implementation ofQAprocess improvements.

•     Ensure all activities are carriedoutin a safe manner and accordingtoWork,HealthandSafety regulations.

•     Assistininternal auditsforcompliance with FMC quality systems.

•     Assistinintroduction of global documents, policiesforeffective implementation on site

•     Carry outother projects as directedbytheSr Quality Assurance Manager.

Business Expansion/Product Introduction

•       Assist Sr QA associateinestablishing quality plans and related activities for Smithfield.

•       Assist Sr QA associate in managing site QMS effectively, ensure ISO and EU MDR certificationismaintained during project roll overs.

EnsureQA/productcompliancemaintainedfor Smithfieldproductprofile (both Smartbags and ProcedurePacks)

Description of Qualification, Key Skills, Personal Attributes:

•   A tertiary qualification inarelevant scientific discipline or equivalent.

•   Minimum 1-year experience inaGMP, Medical Devices and/or ISO certified environment.

•   Excellent written and verbal communication skills.

•   Abilitytomanageahighthroughput of work while meeting quality and business requirements and deadlines by having excellent organisational skills.

•    Computer literacy.

•    Good English Literacy and numerical skills.