CSV Validation Specialist: Data & Compliance Expert

Groupe ProductLife; Firenze; Ibrido; EUR 55.000 - 75.000; Tempo pieno

Descrizione del lavoro

Groupe ProductLife seeks a Validation Specialist (Data & Compliance) in Florence, Italy, to lead CSV efforts within GxP/regulatory frameworks. The role involves coordinating validation activities, preparing key documentation, and ensuring data integrity and lifecycle compliance across client projects.

The candidate should have 4–5 years of experience, a STEM degree, fluent Italian and English, and be available for onsite work in Florence. Travel may be required.

Competenze

• Knowledge of GxP regulations and GMP requirements applicable to computerized systems.
• Good understanding of GAMP 5, EU GMP Annex 11, and 21 CFR Part 11.
• Experience with Computerized System Validation (CSV) lifecycle and validation methodologies.
• Understanding of software development lifecycle (SDLC) and computerized systems lifecycle management.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

Mansioni

• Plan, coordinate, and execute CSV activities for client projects per GAMP 5, GMP, EU GMP Annex 11, and 21 CFR Part 11.
• Prepare, review, and manage validation documentation (Plans, Risk Assessments, URS, IQ/OQ/PQ, Validation Reports).
• Support Data Integrity compliance per ALCOA+ principles and regulatory requirements.
• Perform risk assessments to define validation strategies and support regulatory compliance.
• Support Change Control, Deviations, CAPAs, periodic reviews, and validation lifecycle activities.
• Collaborate with QA, IT, Engineering, Manufacturing, QC, and Validation teams to deliver validation projects.
• Assess impact of software implementations, upgrades, and changes on validated systems.
• Draft/update SOPs, VMPs, and other GMP documents for client projects.
• Provide validation/compliance support during audits and regulatory inspections.
• Contribute to multiple client projects ensuring timely, high-quality delivery.

Conoscenze

GxP regulations

GAMP 5

EU GMP Annex 11

21 CFR Part 11

CSV lifecycle

SDLC

CS lifecycle management

Microsoft Office Suite

Teamwork

Proactivity

Problem solving

Interpersonal skills

Team management

Travel flexibility

Formazione

Bachelor’s or Master’s degree in Engineering, Computer Science, Information Technology, Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related field

Strumenti

Microsoft Office Suite

Descrizione del lavoro

Groupe ProductLife seeks a Validation Specialist (Data & Compliance) in Florence, Italy, to lead CSV efforts within GxP/regulatory frameworks. The role involves coordinating validation activities, preparing key documentation, and ensuring data integrity and lifecycle compliance across client projects.

The candidate should have 4–5 years of experience, a STEM degree, fluent Italian and English, and be available for onsite work in Florence. Travel may be required.