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 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 and Clinical Development and 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 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 thus related to CSV.
Collaborate with the respective Functional Area Heads
Collaborate with the respective Global and Regional Quality Leads and functions
Foster a continuous improvement mentality within
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 other partners for resolution
Manage 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 inspections
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
Develop, maintain and provide 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
Maintain 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 Integrity
Ensure information sharing and action taking
Maintain the Quality System in a compliant state with a changing regulatory environment
Recognised industry committee participation
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
Ensure SOPs/ WPs mirror the actual company processes by working with process subject matter experts and key stakeholders
Support the validated state of computerised systems
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