Affiliate Quality Operations Executive

Reference: VR-AQOE-01
Job Type: Temporary
Job Type: Full-time
Location: Walton Oaks, Tadworth
Duration: 6 months
Working Hours: 37 hours a week
Job Description:

Red Eagle Recruitment (AGY) is looking to recruit an Affiliate Quality Operations Executivefor our client, a global pharmaceutical manufacturer based in Walton Oaks, Tadworth.

The Quality Operations Executive Role supports customer complaints, batch release and Logistic Service Provider Oversight management and provision of a Quality Assurance service to the country business units and platform lines in accordance with internal quality standards to ensure a high quality performance of supply and distribution activities

Major Duties:

  • Management of customer complaints related to product quality issues.
  • Management of communications with local and regional stakeholders related to product quality complaints
  • Support for the administrative release of products approved for distribution into the UK market supply chain
  • Provide a final check and GDP review of product transportation documentation
  • Liaise with the Business Units to prioritise batch release based on urgency of market needs, achieving Service Level Agreement.
  • Maintain the filing of reference documents to include artwork, Certificates of Analysis etc.
  • Compiling Key Performance Indicator figures for reporting purpose to the UK business and Quality organisation.
  • Monitor quarantine product movement and provide status control.
  • Participate in the quality oversight of managed third party contractors, manufacturers, local packaging/labelling partners, analytical laboratories and distribution centres.
  • Assist with the Management and tracking of rework activities and final release at contract repackaging sites.
  • Assist with Management and tracking to final disposition returns from paying customers back to LSPs.
  • Provide input to the update of SOPs /Policies/Working Instructions offering the local perspective and impact
    Product Quality Issues Management and Escalation
  • Inform Quality Management of significant product quality complaints as per Pfizer standards
  • Contribute to product quality investigations (e.g alleged counterfeits, product diversions)
    Metrics and Trending
  • Assist with the collection of data and metrics on the performance of the complaints function as per local standards
  • Support inspection readiness efforts in collaboration with internal stakeholders, Business Units, and Platform Line representatives
  • Support local GxP regulatory authority inspections as per Pfizer standards.
  • Support internal audits/Self Inspections within the scope of QO to ensure compliance
  • with GMP/GDP activities
  • Assist with completion or follow-up of audit Corrective & Preventive Actions (CAPAs).

 

Skills, Knowledge, Qualifications and Experience

 

  • Life Sciences technical degree is required: BS or MSc
  • Some knowledge of the regulatory GDP/GMP compliance issues relating to manufacturing and distribution of medicinal products
  • Previous experience in a GMP/GDP role in a regulated environment is valued
  • Some knowledge and understanding of UK, and EU legislation, guidelines and procedures relating to GxP

This is a 6 month fixed term contract, working 37 hours a week Monday to Friday. This is paying an hourly rate of £16.00 per hour

To find out more and to be considered for the role of Affiliate Quality Operations Executive, please apply via your CV.

 

 


How to apply:

For further information on this vacancy please contact:
Folkestone: 01303 851 133 E-mail: jobs@redeagle.jobs
Please quote the job reference and attach a recent CV if available.



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