Data Integrity & CSV Quality Expert for the site Borgo San Michele LT, Italy

Aenova Group; Latina; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical manufacturer in Latina, Italy, is seeking a Data Integrity & CSV Quality Expert. You will lead compliance programs and oversee the Computer System Validation lifecycle. The ideal candidate has a degree in a related scientific field and 3-5 years of relevant experience. Excellent communication skills in English are mandatory. Full-time position available with opportunities for impact in the pharmaceutical industry.

Competenze

• 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.
• Excellent English communication skills required.

Mansioni

• Lead and maintain the Site Data Integrity and CSV programs.
• Oversee the full Computer System Validation lifecycle.
• Define and monitor Data Integrity governance and perform risk assessments.

Conoscenze

Computer System Validation

Data Integrity

Communication

Analytical Skills

Teamwork

Formazione

Degree in Engineering, Computer Science, Chemistry, Pharmaceutical Technology

Strumenti

SAP

LIMS

TrackWise

SCADA

EBR

Empower

Descrizione del lavoro

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: [phone]

• 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