SENIOR COMPUTER SYSTEM VALIDATION CONSULTANT

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.Due to our constant growth, we are looking for a Senior CSV Consultant to support our project in Spain (Madrid).You will be responsible forLead and execute Computer System Validation and Data Integrity projects, ensuring compliance with GxP regulations such as 21 CFR Part 11, EU GMP Annex 11 and other relevant regulations and guidelines.Collaborate with cross-functional teams, including IT, Quality Assurance and Regulatory Affairs, to ensure successful project execution.Develop and execute a strategic CSV plan that aligns with the company's overall compliance and quality objectives. This includes defining validation strategies, risk assessment methodologies, and validation lifecycle models.Oversee the development and review of comprehensive validation documentation, including Validation Plans, URS, FS, IQ/OQ/PQ protocols, validation reports, and traceability matrices.Conduct risk assessments for computer systems, identify potential vulnerabilities, and implement risk mitigation strategies.Establish and maintain a robust change control process to manage system changes and updates in compliance with validation requirements.Provide guidance on validation testing methodologies, including test design, execution, and documentation. Ensure that testing meets regulatory expectations.Train and mentor junior consultants and client staff on CSV principles and practices.About youBachelor's or Master’s degree in Computer Science, Engineering, Life Sciences or a related field;English language proficiency in speaking and writing (at least B2 level);Spanish language proficiency in speaking and writing (at least B2 level);4+ years of experience in Computer System Validation within the pharmaceutical industry;In-depth knowledge of GxP regulations, 21 CFR Part 11, EU Annex 11 and other relevant guidelines;Proven experience in leading CSV projects and teams;Strong analytical and problem-solving skills;Professional team collaborator with strong communication skills in a consultancy setting.Location:Madrid (Spain) on-siteTravel availability: 50% of the timePart of the first project will be in South Africa (Cape Town)Next StepsUpon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.If there's a positive match, a technical interview with the Hiring Manager will be arranged.In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal. Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.Working at PQE GroupAs a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.