Descripción de la oferta
OverviewTo execute and develop Computer System Validation (CSV) projects, both from a documentation and execution perspective, ensuring compliance with internal procedures, applicable regulatory requirements, and client expectations.Key ResponsibilitiesExecute technical and documentation activities within CSV projects under the guidance of the Project Leader.Collaborate closely with the assigned consulting team to ensure project consistency and quality.Ensure compliance with agreed timelines, deliverables, and quality standards.Regularly report project progress, incidents, and action plans to the Project Manager.Represent us in front of clients, safeguarding the company’s interests and corporate image.Accurately register and keep up to date working hours, expenses, and travel records.Main DutiesRequest, review, and analyze technical information required to adapt validation documentation to the client’s methodology.Draft, review, and manage CSV consultancy documentation in accordance with our standards and current regulatory requirements.Perform validation activities, testing, training sessions, or technical support at the client’s facilities or at our HQ.Identify, document, and communicate any deviations or anomalies detected during project execution.Participate in data integrity assessments, infrastructure qualification, and software validation activities (ERP, QMS, LIMS, SCADA, HMI, etc.).Requirements Academic BackgroundBachelor’s Degree or Diploma in Pharmacy, Engineering, Life Sciences, or related fields.Higher Vocational Training (HNC/HND) will be considered if supported by relevant professional experience.Training in project management.Specific courses in Computer System Validation, GAMP 5, Data Integrity, or related topics.Technical Knowledge (Required)Solid knowledge of GxP regulations and regulatory requirements applicable to computerized systems.Experience in validation of laboratory systems, SCADA, ERP, QMS, LIMS, and similar platforms.Good understanding of pharmaceutical industry processes and operations.LanguagesEnglish: Advanced level (ability to manage information, write, defend and have fluent conversations in the language)Professional Experience2 to 4 years of experience in a similar role (CSV Consultant/CSV Technician).Previous experience participating in end-to-end CSV projects (documentation and execution).Experience working with clients and providing technical and documentation support.Exposure to international validation projects is a plus.Additional RequirementsAvailability to travel (national and international). As for right now, the main projects are located across Cataluña. It will be desirable that the candidate has a driver’s license.
#J-18808-Ljbffr
