Computer Validation Auditor

My client are looking for an experience CSV Auditor , The main task is to manage and perform audits with focus on Computer System Validation (CSV) audits.The role is offered on a 1 year contract . The role is based in the UK and will involve travelling to sites across Europe .Additional tasks are to support the continuous improvement of the Quality System, the inspection management, the regulatory intelligence activities, the SOP and WP management, and the 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 REQUIREDDegree in natural science or equivalent business experienceSeveral years of Information Technology (IT) industry/pharmaceutical industry/medical devices industry/Regulatory Authority or otherwise relevant experience, preferably including Quality Assurance for Manufacturing, Pharmacovigilance and Clinical Development and Computerised System Validation and Data IntegrityExpert 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 PharmacovigilanceExperience as a Lead Auditor on internal audits and external vendor audits.Experienced in GxP related CSV audits and inspectionsKnowledge and understanding of computerised systems in the GxP environment, experience in software validation and/or developmentUnderstanding of computer hardware and network/infrastructure requirementsSupport the development, implementation, continuous improvement and documentation Companies’ Quality SystemEnsure 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 thus related to CSV.Collaborate with the respective Functional Area HeadsCollaborate with the respective Global and Regional Quality Leads and functionsFoster a continuous improvement mentality withinEnsure the establishment and maintenance of the required Quality documentation and ensure appropriate quality standards are adhered to in the management of this documentationIdentify process gaps and deficiencies in the Quality System, liaise and collaborate continuously with other Functional Areas and other partners for resolutionManage planned and unplanned deviations reported by the Functional Areas and support them by resolving the deviations.Develop and support global compliance training procedures in collaboration with other Ocompanies and provide training in the area of expertise as assigned.Support inspectionsCoordinate/Support the preparation for GxP inspectionsCoordinate/Support the responses to Regulatory AuthoritiesSupervise and provide input to the corrective and preventive actionsFollow-up on the development, implementation and completion of corrective and preventive actions with the inspected Functional AreasMaintain a tracking tool for inspections, findings and corrective and preventive actionsSupport the audit processDevelop, maintain and provide input to an adequate audit plan for global, regional and local, computerised systems and compliance processesSelect and manage qualified service providers for Global Quality, e.g., contract auditorsManage audits and contract auditors in line with the audit plan, business model and applicable proceduresPlan, supervise, conduct, and support internal and external GxP auditsFollow-up on the development, implementation and completion of corrective and preventive actions with internal and external auditeesMaintain a tracking tool for audits, findings and corrective and preventive actionsProvide input for the development and maintenance of the audit tracking toolSupport Regulatory IntelligenceMaintain an overview over the relevant regulatory requirements and state-of-the-art knowledge of development in the professional regulatory environment to be able to provide guidance for timely adaptation of procedures.Evaluate impact of regulatory changes for the Quality System, in particular related to IT Compliance, CSV & Data IntegrityEnsure information sharing and action takingMaintain the Quality System in a compliant state with a changing regulatory environmentRecognised industry committee participationSupport 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 regulationsEnsure SOPs/ WPs mirror the actual company processes by working with process subject matter experts and key stakeholdersSupport the validated state of computerised systemsProvide 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 applicabilitySupervise and provide input to the corrective and preventive actionsFollow-up on the development, implementation and completion of corrective and preventive actions with the Functional AreasEnsure that relevant validation and technical/ IT-infrastructure/ data integrity activities comply with applicable global, regional and local compliance requirements and are documented accordinglyLiaise and collaborate with validation and IT expertsProvide advice and act as project liaisonProvide sound advice and interpretations related to current GxP guidelines and regulations on CSV& Data Integrity to Senior Management and employeesBe accountable for quality-related input in decision making processes with relevance for GxP complianceAct as quality liaison for assigned projects