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Auditor, GMP Compliance and Supplier Management - Seqirus - 345BR

Liverpool, ENGLAND, United Kingdom

Posted: 3-Oct-2016

Ref#: 12345699036



Are you looking for a rewarding career in a market-leading and innovative company?

Seqirus is the new global company created from the combined strength and expertise of bioCSL and the influenza vaccines business formerly owned by Novartis. In July 2015, bioCSL and the influenza vaccines of Novartis joined forces to create what is now the second largest influenza vaccine company in the world.  With extensive research and production expertise and manufacturing plants in the US, UK, Germany and Australia, Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. 

Our site in Liverpool is a Centre of Excellence for egg-based influenza vaccine manufacturing – it is one of the biggest biotechnology sites in Europe and the only injectable influenza vaccine manufacturer in the UK. It also produces the only licensed adjuvanted seasonal influenza vaccine. 

Currently for our team based in Liverpool we are looking for the GMP Compliance and Supplier Management Auditor. The position will plan and execute both self-inspections as well as external suppliers and 3rd party audits across European sites. 

Auditor - GMP Compliance and Supplier Management
 

Accountabilities:
 
  • Management of Self inspections and Third Party audits (plan, perform to plan, report, track and verify associated CAPAs) including timely execution and monitoring.
  • Management of Suppliers / GMP service providers/ Contract Laboratories/ Contract Management Organisations (Quality Agreements/ Change Notifications/ Annual Reviews/ Approved Supply List/ Quality Information Records).
  • Attendance at Material Review Committee and Supplier Change Notification Meeting. Progress actions identification.
  • Root Cause Analysis for deviations raised and progress to completion with associated CAPAs.
  • Support introduction of new materials / suppliers.
  • Inspection Preparation (Verification of Audit packs / Area walk-throughs) and tracking / monitoring audit commitments via Trackwise system. Coordination and/or support responses to observations.
  • Training of staff in applicable compliance related procedures and own training kept up to date.
  • Acting as knowledge transfer co-ordinator / representative ensuring any gaps identified are tracked to completion and verified.
  • Support for the Supply Management and 3rd Party processes via cross-site meetings.
  • Timely execution of actions resulting from Health Authority.
 
Profile
 
  • Certified Lead Auditor
  • Scientific Degree
  • Pharmaceutical experience; understanding of cGMP and knowledge of Quality systems
  • Ability to work with cross-functional teams
  • Influencing and interpersonal skills
  • Good Communication skills
  • Good knowledge of MS office and Trackwise systems
  • Trained to competent standard in use of Documentation Management and SAP Systems.

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