Commercial Officer - Hertford, United Kingdom - Neon Healthcare

Description

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 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 Bonafide 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

Job Types:
Full-time, Permanent


Pay:
Up to £32,500.00 per year


Benefits:

• Additional leave
• Company pension
• Free parking
• Private medical insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus scheme

Application question(s):

• Are you able to commute to our office in Hertford SG14 3BZ?

Work Location:
In person


Reference ID:
CO02