Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Manage and perform audits focused on Computer System Validation across Europe.
- Company: Join a leading company in the pharmaceutical and medical devices industry.
- Benefits: Enjoy opportunities for travel, professional growth, and collaboration with global teams.
- Why this job: Be part of a culture that values continuous improvement and quality assurance in healthcare.
- Qualifications: Degree in natural science or equivalent experience; several years in IT/pharmaceutical/medical devices.
- Other info: Experience as a Lead Auditor is preferred; knowledge of GxP regulations is essential.
The predicted salary is between 36000 - 60000 £ per year.
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 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
Computer Validation Auditor employer: Parkside Recruitment
Contact Detail:
Parkside Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Computer Validation Auditor
✨Tip Number 1
Familiarize yourself with the latest regulations and guidance documents related to Computer System Validation (CSV) and Data Integrity. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in this rapidly evolving field.
✨Tip Number 2
Network with professionals in the pharmaceutical and IT industries, especially those who have experience in GxP audits. Attend relevant conferences or webinars to connect with potential colleagues and learn about industry best practices.
✨Tip Number 3
Prepare for the interview by practicing common audit scenarios and questions related to CSV. Being able to articulate your past experiences and how they relate to the role will set you apart from other candidates.
✨Tip Number 4
Showcase your ability to foster a continuous improvement mentality. Be ready to discuss specific examples where you've identified process gaps and implemented solutions, as this aligns closely with the responsibilities of the role.
We think you need these skills to ace Computer Validation Auditor
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Computer System Validation (CSV) and Quality Assurance. Emphasize your expertise in GxP related audits and any specific regulations you are familiar with.
Craft a Strong Cover Letter: In your cover letter, express your passion for quality management and your understanding of the pharmaceutical and IT industries. Mention specific experiences that demonstrate your ability to manage audits and improve quality systems.
Highlight Relevant Qualifications: Clearly outline your degree in natural science or equivalent experience. Include any certifications or training related to CSV, GxP, or Quality Assurance that would make you a strong candidate.
Showcase Your Audit Experience: Detail your experience as a Lead Auditor, including the types of audits you've conducted and any significant findings or improvements you've implemented. This will demonstrate your capability to handle the responsibilities of the role.
How to prepare for a job interview at Parkside Recruitment
✨Showcase Your Relevant Experience
Make sure to highlight your experience in Computer System Validation (CSV) and any relevant audits you've conducted. Discuss specific projects or roles where you managed audits, focusing on your contributions and the outcomes.
✨Demonstrate Knowledge of Regulations
Be prepared to discuss your understanding of key regulations and guidance documents related to CSV, Data Integrity, and GxP. This shows that you are not only knowledgeable but also up-to-date with industry standards.
✨Emphasize Continuous Improvement Mindset
Talk about how you've contributed to the continuous improvement of quality systems in your previous roles. Share examples of how you've identified process gaps and implemented solutions to enhance compliance.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills in real-world situations. Think of examples where you had to manage deviations or coordinate responses to regulatory authorities, and be ready to explain your approach.
