Data Integrity & CSV Quality Expert for the site Borgo San Michele LT, Italy
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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.
Act as subject matter expert during audits and inspections, providing training and promoting a strong data integrity culture.

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.

Applications must be submitted in English. Applications in Italian or any other language will not be considered.
If you have any questions, I - Lukas Rödder / Human Resources - will be happy to help you: +49 151 16260074

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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Seniority level
Mid‑Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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