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 CSVto support our projects in Barcelona, Spain. You will be responsible for 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. About you Bachelors or Master's degree in a relevant scientific or engineering discipline (e.g., Computer Science, Engineering, Chemistry, Pharmacy, or related fields). In-depth knowledge of relevant regulations, guidelines, and industry standards related to CSV, data integrity, and computerized systems (e.g., GAMP 5, 21 CFR Part 11). Effective communication and interpersonal skills to collaborate with stakeholders at all levels of the organization. Next Steps Upon 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 Group As 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.
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