Quality Assurance Officer

4 weeks ago

Hertford Hertfordshire, United Kingdom NEON HEALTHCARE LTD Full time

Job Description

We are currently recruiting an experienced QA Officer for our expanding team based in Hertford (just north of the M25). We are a UK-based pharmaceutical company dedicated to developing, re-developing, and distributing prescription only medicines to the United Kingdom. We have both commercially branded and generic products for which all manufacturing is outsourced.

We are currently in an exciting period of growth in the development of new products, and our expansion into other markets has resulted in this excellent opportunity to take on a newly created position in our quality function.

The successful candidate will manage all aspects of Good Manufacturing and Distribution Practice and oversee the direction and maintenance of a suitable Quality Management System across Neon Healthcare Ltd.

The overall purpose of this role is to ensure compliant and efficient execution of Neon Quality Batch Release Activities whilst supporting the product lifecycle and Quality Management System.

You will deliver and maintain excellent service levels, support your team to ensure internal and external customer satisfaction.

Responsibilities:

·Ensure Deviations, CAPAs and change controls for which you are the owner are progressed in a compliant and timely manner

·Ensure customer complaints are satisfactorily investigated and communicated

·Understand, and accurately follow internal quality procedures and GMDP in accordance with guidelines and legislations.

·Ensure batches are QA reviewed as required to support the business needs

·Support the batch release process through the preparation and provision of necessary documentation and document reviews highlighting any issues/gaps and communicating these for wider team resolution.

·Meet timelines and metrics of the quality systems

·Collection of data to present to wider team and Senior management team with respect to KPI’s for QMRs

·Internal Audit Management with lead Auditor

·Maintenance and compiling of annual PQRs

·Support the running and day to day activities of the quality system

·Customer/supplier Bona-fide qualification

·CMO interaction to progress QMS records towards closure

·Risk assessment using approved method for accurate classification and/or identification of required actions

·Ensure timely completion of requirements with respect to recalls

·Creation/update of SOPs as well as Document control with respect to tracking of review dates.

·Supporting the wider team with New product integration

Required Knowledge / Experience

·Working in a QA capacity for minimum of 3 years

·Understanding of quality management systems

·Experienced in management of Deviations, Complaints, Change controls and CAPA

·Awareness of applicable GMP/GDP requirements

·Ability to identify and raise deviations

·Report writing

·Root cause analysis

·Risk assessment/impact assessment

·Use of Eudra GMDP and MHRA GMDP website

·Tracking records/actions and due dates

·Ability to multitask as well as prioritise

·Good written and verbal communications

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