London, United Kingdom
Ongoing relation / part-time
• Conduct of Internal and supplier Audits, including for cause audits across the GXPs
• Annual risk assessments across the business function to identify the audits to be scheduled in across a 5-year period.
• Management of global audit schedule and ensuring all audits are completed on time and within budget.
• Management of GxP audit consultants
• Gap Analysis of systems, bridging gaps by creation of procedures and training workshops.
• Provision of QA consultation services to both external and internal stakeholders.
• SOP creation, development implementation and training
• Gap analysis
• Hosting client audits and regulatory inspections
• CAPA Management
• Management and delivery of the global audit program
• Line manager to 5 auditors
• CAPA metric development
• Awareness of current PV and GCP regulations
• Driving due diligence activities for all vendors/sub-contractors used
• Acting as Client Liaison and main point of contact for any quality related issues
• Reviewing and approving deviations and assessing impact to the global PV system
• Leading the quality assurance department as being a department of excellence and a 'go to' place for all quality related issues.
• Commercialization of the Quality Assurance department
• Risk assessing new clients, projects, audits and vendors.
• SOP development, writing and implementation
• Developing SOPs, Work Instructions, Quality Manual
• Driving Gap Analysis
• Developing strategies for working towards retaining accreditation
• Escalating GCP and GCLP Compliance Issues.
• Promoting Quality Culture Awareness within the company
• Hosting all client audits and promoting the company Quality Management System
• Responsible for management and delivery of the audit program to include internal systems and vendor audits.
• Driving CAPA to completion for both internally identified GCP/GCLP non-compliance as well as non-compliance identified in audit.
• Generating metrics from reported deviation, CAPA to assist in process improvements
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