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- 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 a one-year contract with opportunities for travel and professional growth.
- Why this job: Be part of a dynamic team improving quality systems and making a real impact.
- Qualifications: Degree in natural science or equivalent experience; several years in IT or pharma required.
- Other info: Collaborate with global leaders and enhance your expertise in GxP compliance.
The predicted salary is between 36000 - 60000 £ per year.
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 and is based in the UK, involving travel 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 experience in the 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, particularly 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
Responsibilities include:
- Supporting the development, implementation, continuous improvement, and documentation of the Companies’ Quality System
- Ensuring continuous improvement and enhancement of the Quality System by supporting global metrics generation and ‘lessons learned from audit/inspection’
- Covering GxP related Functional Areas, specifically those related to CSV
- Collaborating with the respective Functional Area Heads
- Fostering a continuous improvement mentality
- Identifying process gaps and deficiencies in the Quality System
- Managing planned and unplanned deviations reported by the Functional Areas
- Developing and supporting global compliance training procedures
- Coordinating/supporting the preparation for GxP inspections
- Supervising and providing input to corrective and preventive actions
- Maintaining a tracking tool for inspections, findings, and corrective and preventive actions
- Developing, maintaining, and providing input to an adequate audit plan for global, regional, and local computerised systems and compliance processes
- Selecting and managing qualified service providers for Global Quality
- Planning, supervising, conducting, and supporting internal and external GxP audits
- Maintaining a tracking tool for audits, findings, and corrective and preventive actions
- Maintaining an overview of relevant regulatory requirements and state-of-the-art knowledge of developments in the professional regulatory environment
- Supporting the management of global, regional, and local Standard Operating Procedures (SOPs) and Working Practices (WPs)
- Providing business support as Global Quality for routine software/infrastructure lifecycle activities
- Liaising and collaborating with validation and IT experts
- Providing sound advice and interpretations related to current GxP guidelines and regulations on CSV & Data Integrity
- Acting as quality liaison for assigned projects
Contact Detail:
Parkside Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Computer Validation Auditor
✨Tip Number 1
Network with professionals in the pharmaceutical and IT industries. Attend relevant conferences or webinars where you can meet people who work in Computer System Validation (CSV) and Quality Assurance. This can help you gain insights into the role and potentially get referrals.
✨Tip Number 2
Familiarise yourself with the latest regulations and guidance documents related to CSV and Data Integrity. Being well-versed in these areas will not only boost your confidence but also demonstrate your commitment to staying updated in this ever-evolving field.
✨Tip Number 3
Consider reaching out to current or former employees of the company you're applying to. They can provide valuable insights about the company culture, expectations for the role, and tips on how to stand out during the interview process.
✨Tip Number 4
Prepare for potential interview questions by practising your responses to common scenarios faced in CSV audits. Think about specific examples from your past experience that highlight your problem-solving skills and ability to manage compliance effectively.
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. Emphasise your expertise in the IT and pharmaceutical industries, as well as any lead auditor experience you have.
Craft a Strong Cover Letter: In your cover letter, explain why you're passionate about CSV auditing and how your background aligns with the company's needs. Mention specific projects or experiences that demonstrate your ability to manage audits and improve quality systems.
Highlight Relevant Qualifications: Clearly list your qualifications, such as your degree in natural science or equivalent experience. Include any certifications related to GxP, CSV, or Quality Management that would make you stand out.
Showcase Continuous Improvement Mindset: Demonstrate your commitment to continuous improvement in your application. Provide examples of how you've identified process gaps and implemented solutions in previous roles, particularly in relation to quality systems.
How to prepare for a job interview at Parkside Recruitment
✨Know Your Regulations
Familiarise yourself with the relevant regulations and guidance documents related to Computer System Validation (CSV) and Data Integrity. Be prepared to discuss how these regulations impact quality assurance processes in the pharmaceutical and IT industries.
✨Demonstrate Your Audit Experience
Highlight your experience as a Lead Auditor, especially in GxP related audits. Share specific examples of audits you've conducted, the challenges you faced, and how you resolved them to showcase your problem-solving skills.
✨Showcase Continuous Improvement Mindset
Discuss your approach to continuous improvement within quality systems. Provide examples of how you've identified process gaps and implemented changes that enhanced compliance and efficiency in previous roles.
✨Prepare for Technical Questions
Expect technical questions regarding computerised systems, software validation, and IT infrastructure. Brush up on your knowledge of these areas and be ready to explain how they relate to GxP compliance and quality management.
