Senior Computer System Validation Consultant

1 mese fa

Bardi, Italia Pqe Group A tempo pieno

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.Following a new opportunity, we are currently looking for a Senior Computer System Validation Consultant to support one of our clients in Caponago (MB), Italy.You will be responsible for:Lead and execute Computer System Validation projects, ensuring compliance with GxP, 21 CFR Part 11, and other relevant regulations and guidelines;Develop and implement CSV strategies, plans, and protocols (IQ/OQ/PQ) for various computer systems, including laboratory systems, manufacturing systems, and enterprise applications;Perform risk assessments and develop risk mitigation strategies for computer systems;Conduct validation activities, including documentation review, test execution, and deviation management;Provide expert guidance on regulatory requirements and industry best practices related to CSV;Collaborate with cross-functional teams, including IT, Quality Assurance, and Regulatory Affairs, to ensure successful project execution;Train and mentor junior consultants and client staff on CSV principles and practices;Stay current with industry trends and regulatory changes to ensure the company's CSV practices remain up-to-date;Prepare and present validation reports and findings to clients and regulatory agencies.About you:Bachelor'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);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.Location: Caponago (MB), Italy – 50% on site jobTravel availability: up to 50% of the time.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 from the Hiring Manager interview, the 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. #J-18808-Ljbffr

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