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Head of GxP Audit & Compliance

Posted 21 days ago

  • Cuddington, Cheshire
  • Any
  • External
  • Expired - 2 months ago
Summary
Dechra Pharmaceuticals are looking for an experienced auditing professional to join our manufacturing division on a remote basis.
Support the GxP and Regulatory compliance of Dechra Products by developing audit systems which will ensure process and product compliance with applicable GMPs/GDPs throughout the product lifecycle.
Develop, approve, and monitor the risk based GxP audit programme and budget for Dechra DPMS. Develop and support inspection readiness at Dechra Internal Manufacturing sites, sustaining their ability to successfully conclude regulatory inspections for Dechra's products.
Provide US and European regulatory intelligence, train Subject Matter Experts and provide internal consultancy for quality compliance implementation and FDA/EU GMP/GDP remediation projects in the Dechra Internal Manufacturing network.
Frequent global travel is required with this role, and you will need to travel to our Northwich site once a month.
Main Responsibilities
Support all regulatory authority inspections at Dechra Internal Manufacturing Sites and at key Identified External Network Manufacturing Sites by providing expertise (e.g., stress tests, mock inspections, inspection preparations, backroom support and review or preparation of responses to deficiencies) and on-site presence as required.
Develop audit systems to ensure key elements of the Dechra GxP Quality Management System and the requirements of ...
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