Affiliate Quality Operations Executive
Job Type: Temporary
Job Type: Full-time
Location: Walton Oaks, Tadworth
Duration: 6 months
Working Hours: 37 hours a week
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
- 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.
For further information on this vacancy please contact:
Folkestone: 01303 851 133 E-mail: firstname.lastname@example.org
Please quote the job reference and attach a recent CV if available.
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