Data Integrity

1 settimana fa

Latina, Italia Aenova Holding A tempo pieno

for the site Borgo San Michele LT, Italy Would you like to make a valuable contribution to the health of patients? And do something really meaningful on your own responsibility? Then we look forward to hearing from you Excellence beyond manufacturing - that's what we stand for as Aenova, one of the world's leading contract manufacturers and developers for the pharmaceutical industry with 4,000 employees at 15 sites. Latina is a leading centre of excellence in sterile liquid production, with a strategic investment plan to become one of Europe's foremost hubs. Your key responsibilities - Lead and maintain the Site Data Integrity and CSV programs, ensuring compliance with GxP and corporate standards (EU GMP Annex 11, 21 CFR Part 11, ALCOA+). - Oversee the full Computer System Validation (CSV) lifecycle, including planning, testing, documentation, and periodic review. - Define and monitor Data Integrity governance, perform risk assessments, and ensure compliant system implementation across Quality, Manufacturing, Engineering, and Laboratory systems. - Support deviation, CAPA, and change control management related to computerized systems and data integrity. Your profile - Degree in Engineering, Computer Science, Chemistry, Pharmaceutical Technology, or related scientific field. - Minimum 3-5 years of experience in Computer System Validation and Data Integrity within a pharmaceutical GMP environment. - Deep knowledge of EU GMP Annex 11, FDA 21 CFR Part 11, ICH Q9, and Data Integrity guidelines (EMA, MHRA, FDA, WHO). - Strong understanding of IT systems used in GxP environments (e.g., SAP, LIMS, TrackWise, SCADA, EBR, Empower). - Excellent communication, analytical, and teamwork skills, with very good English proficiency. **Please note**: Applications **must be submitted in English**. Applications in Italian or any other language will **not be considered**. Your motivation Are you looking for new challenges in a highly competitive environment? And you want to tackle them creatively and on your own responsibility? Do you prefer a "get-it-done" culture and think in terms of solutions rather than problems? What are you waiting for? We would be happy to explain our corporate benefits in a personal conversation If you have any questions, I - Lukas Rödder / Human Resources - will be happy to help you: +49 151 16260074 Online seit: 06.11.2025 - Beschäftigungsverhältnis Vollzeit - Unternehmen Haupt Pharma Latina S.r.l. - Bereich Qualität ** Kontakt** Haupt Pharma Latina S.r.l. - Member of the Aenova Group - Strada Statale 156 dei Monti Lepini - 04100 Borgo San Michele LT‚ Italy

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