Computer Validation Auditor

My client is looking for an experienced CSV Auditor. The main task is to manage and perform audits with a focus on Computer System Validation (CSV) audits. The role is offered on a 1-year contract, based in the UK, and will involve travelling to sites across Europe.

Additional tasks include:

• Supporting the continuous improvement of the Quality System
• Inspection management
• Regulatory intelligence activities
• SOP and WP management
• Project liaison activities

In close collaboration with the Head of Global Quality Management of GCP, CSV & GVP, Senior Director Global Quality Management, and the CSV Audit Lead.

QUALIFICATIONS/EXPERIENCE REQUIRED

• Degree in natural science or equivalent business experience
• Several years of Information Technology (IT) industry/pharmaceutical industry/medical devices industry/Regulatory Authority or otherwise relevant experience, preferably including Quality Assurance for Manufacturing, Pharmacovigilance, Clinical Development, Computerised System Validation, and Data Integrity
• Expert knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Computerised System Validation, Data Integrity, Manufacturing, Pharmacovigilance, Clinical Development, Medical Device, IMP management, Regulatory Affairs, and Pharmacovigilance
• Experience as a Lead Auditor on internal audits and external vendor audits
• Experienced in GxP related CSV audits and inspections
• Knowledge and understanding of computerised systems in the GxP environment, experience in software validation and/or development
• Understanding of computer hardware and network/infrastructure requirements

Support the development, implementation, continuous improvement, and documentation of the Companies’ Quality System. Ensure continuous improvement and enhancement of the Quality System by supporting global metrics generation and ‘lessons learned from audit/inspection’. Cover GxP related Functional Areas, specifically those related to CSV.

Collaborate with the respective Functional Area Heads and Global and Regional Quality Leads and functions. Foster a continuous improvement mentality within the organisation. Ensure the establishment and maintenance of the required Quality documentation and ensure appropriate quality standards are adhered to in the management of this documentation.

Identify process gaps and deficiencies in the Quality System, liaise and collaborate continuously with other Functional Areas and partners for resolution. Manage planned and unplanned deviations reported by the Functional Areas and support them in resolving the deviations.

Develop and support global compliance training procedures in collaboration with other companies and provide training in the area of expertise as assigned. Support inspections and coordinate/support the preparation for GxP inspections.

Coordinate/support the responses to Regulatory Authorities, supervise and provide input to the corrective and preventive actions. Follow up on the development, implementation, and completion of corrective and preventive actions with the inspected Functional Areas.

Maintain a tracking tool for inspections, findings, and corrective and preventive actions. Support the audit process by developing, maintaining, and providing input to an adequate audit plan for global, regional, and local computerised systems and compliance processes.

Select and manage qualified service providers for Global Quality, e.g., contract auditors. Manage audits and contract auditors in line with the audit plan, business model, and applicable procedures. Plan, supervise, conduct, and support internal and external GxP audits.

Follow up on the development, implementation, and completion of corrective and preventive actions with internal and external auditees. Maintain a tracking tool for audits, findings, and corrective and preventive actions.

Provide input for the development and maintenance of the audit tracking tool. Support Regulatory Intelligence by maintaining an overview of the relevant regulatory requirements and state-of-the-art knowledge of developments in the professional regulatory environment to provide guidance for timely adaptation of procedures.

Evaluate the impact of regulatory changes for the Quality System, particularly related to IT Compliance, CSV & Data Integrity. Ensure information sharing and action taking to maintain the Quality System in a compliant state with a changing regulatory environment.

Participate in recognised industry committees and support the management of the global, regional, and local Standard Operating Procedures (SOPs) and Working Practices (WPs). Ensure SOPs/WPs are compliant with applicable requirements and regulations and mirror the actual company processes by working with process subject matter experts and key stakeholders.

Support the validated state of computerised systems and provide business support as Global Quality for routine software/infrastructure lifecycle activities (systems introduction/maintenance/retirement). Provide quality-related input and guidance for computerised system validation activities such as risk and GxP applicability.

Supervise and provide input to the corrective and preventive actions. Follow up on the development, implementation, and completion of corrective and preventive actions with the Functional Areas. Ensure that relevant validation and technical/IT-infrastructure/data integrity activities comply with applicable global, regional, and local compliance requirements and are documented accordingly.

Liaise and collaborate with validation and IT experts. Provide advice and act as project liaison. Provide sound advice and interpretations related to current GxP guidelines and regulations on CSV & Data Integrity to Senior Management and employees.

Be accountable for quality-related input in decision-making processes with relevance for GxP compliance. Act as quality liaison for assigned projects.