Computer system validation consultant

hace 1 semana


Madrid, España PQE Group A tiempo completo

Are you ready to join a world leaderin the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Grouphas been at the forefront of these industries since 1998, with 40 subsidiariesand more than 2000 employees in Europe, Asia and the Americas. Due to a constant growth, we are looking for a Computer System Validation Consultantto join our team in Barcelonaor Madrid, Spain. ❗ This is a hybrid role (2 days working from home) and requires strong Spanish language skillsat a professional level. Responsibilitiesinclude, but are not limited, to the following: Support in Computer System Validation (CSV) activities:Contribute to the execution of CSV projects, ensuring alignment with Gx P requirements, 21 CFR Part 11, EU Annex 11, and applicable guidelines.Preparation of validation documentation:Assist in drafting and reviewing technical documents such as validation plans, protocols (IQ/OQ/PQ), reports, and risk assessments.Execution of testing activities:Participate in protocol execution, test result documentation, and deviation management as needed.Support in risk assessments:Collaborate in collecting information, performing preliminary risk analyses, and defining mitigation actions.Cross-functional collaboration:Work closely with IT, Quality Assurance, and other business functions to ensure proper implementation of compliance requirements.Regulatory awareness:Stay informed about relevant regulations and industry best practices related to computer system validation.Client support:Provide operational and consulting support to clients during CSV activities. Requirements: Bachelor’s or Master’s degree in Scientific or Technical disciplines(Pharmacy, Chemistry, Biology, Engineering, Computer Science, etc.).1–3 yearsof experience in the Pharmaceutical industryor in a related validation/qualification role.Basic to intermediate understanding of Gx P regulations, 21 CFR Part 11, EU Annex 11, and other compliance requirements.Native-level Spanish (mandatory)and good command of English(B1–B2).Familiarity with Gx P-regulated computer systems, test management tools, and CSV-related tools.Strong skills in technical documentationpreparation and updating.Good organizational skills, teamwork attitude, problem-solving mindset, and motivation to grow in the CSV consultingfield. Location:Barcelona or Madrid, Spain 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.



  • Madrid, España PQE Group A tiempo completo

    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 a constant growth, we are looking for a Computer System Validation Consultant...


  • Madrid, España PQE Group A tiempo completo

    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.Si cree que es el candidato ideal para la siguiente oportunidad, envíe su solicitud...


  • Madrid, España PQE Group A tiempo completo

    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.Si cree que es el candidato ideal para la siguiente oportunidad, envíe su solicitud...


  • Madrid, España PQE Group A tiempo completo

    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 a constant growth, we are looking for a Computer System Validation Consultant...


  • Madrid, España PQE Group A tiempo completo

    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.Si cree que es el candidato ideal para la siguiente oportunidad, envíe su solicitud...


  • Madrid, España PQE Group A tiempo completo

    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 a constant growth, we are looking for a Computer System Validation...


  • Madrid, España PQE Group A tiempo completo

    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 a constant growth, we are looking for a Computer System Validation...


  • Madrid, España PQE Group A tiempo completo

    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 a constant growth, we are looking for a Computer System Validation Consultant...


  • Madrid, España PQE Group A tiempo completo

    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 a constant growth, we are looking for a Computer System Validation...


  • Madrid, España PQE Group A tiempo completo

    Are you ready to join aworld leaderin the exciting and dynamic fields of thePharmaceutical and Medical Device industries ?PQE Grouphas been at the forefront of these industriessince 1998 , with40 subsidiariesand more than2000 employees in Europe, Asia and the Americas .Due to a constant growth, we are looking for aComputer System Validation Consultantto join...