Lead Pharmaceutical Auditor
Lead Pharmaceutical Auditor
Who are Dechra?
Dechra is an international specialist veterinary pharmaceuticals and related products business. Our expertise is in the development, manufacture and sales and marketing of high quality products exclusively for veterinarians worldwide.
With offices across 24 countries in Europe and North America, we export to over 50 countries worldwide and have six manufacturing sites.
Where is the role based?
Skipton, North Yorkshire
The Dechra group employ over one thousand people. Revenue in 2018 reached £407.1m
Job Purpose and Key Accountabilities
The role is responsible for supporting implementation and continual improvements of the Quality Management System (QMS) requirements, particularly in relation to audits and Quality Agreements whilst maintaining, GxP and Regulatory compliance.
- Either individually or as part of an audit team, plan, conduct and report external supplier /contractor audits and assessments in line with external audit Standard Operating Procedures (SOPs), ensuring audit files are appropriately maintained
- To support smooth running and continual improvement of the internal and external Dechra audit systems for the Skipton site and demonstrating the use of Quality Risk Management principles.
To provide training to Dechra staff, Act as an internal and external auditor and as an audit mentor to the staff
- Act as ambassador for Quality in Dechra via communicating compliance expectations and projecting a professional attitude to Quality
- To support Client Audits and Competent Authority Inspections at Dechra and present concise and accurate information for queries on external audits as required.
- Authoring and reviewing Quality Agreements with suppliers and clients
- To assist with the management and maintenance of the Quality Management System
- To ensure that appropriate standards of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) are maintained
- To support the development and implementation of regulatory and quality procedures
- To communicate relevant aspects of the quality system to employees, as necessary, in order to support product and service quality
- To assist in providing training to members of staff on relevant components of Quality Management.
- To contribute to continual improvement by formulating reports, trending and data analysis.
- Act as a Subject Matter Expert (SME) for audits and Quality Risk Management
- Participate in meetings with relevant staff in order to discuss audit /assessment findings.
- Ensure corrective action activities associated with all audit observations are agreed and completed in a timely manner.
- Ensure any notification of Supplier compliance issues are impact assessed and actions required are progressed to completion