Data Integrity & CSV Quality Expert

Data Integrity & CSV Quality Expert

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 - thats what we stand for as Aenova one of the worlds leading contract manufacturers and developers for the pharmaceutical industry with 4000 employees at 15 sites. Latina is a leading centre of excellence in sterile liquid production with a strategic investment plan to become one of Europes 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 35 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 : Haupt Pharma Latina S.r.l. Member of the Aenova Group Strada Statale 156 dei Monti Lepini 04100 Borgo San Michele LT Italy

Key Skills

IDS,System Design,Haskell,PCB,Root cause Analysis,Technical Writing,System Security,Federal Aviation Regulations,Warehouse Distribution Experience,Encryption,Product Development,Contracts

Employment Type : Full-Time

Experience : years

Vacancy : 1