CSV Validation Specialist: Data & Compliance

Productlife Group; Italia; In loco; EUR 35.000 - 45.000; Tempo pieno

Descrizione del lavoro

Productlife Group seeks an experienced CSV validation professional in Italy to plan, coordinate, and execute computerized system validation for client projects, ensuring compliance with GAMP 5, GMP, EU GMP Annex 11, and 21 CFR Part 11. You will manage validation documentation, perform risk assessments, and support regulatory inspections.

Ideal candidates have 4-5 years of experience, strong data integrity knowledge, and fluency in Italian and English.

Competenze

• Bachelor's or Master's degree in Engineering, Computer Science, Information Technology, Life Sciences, Pharmacy, Chemistry, Biotechnology, or related field.
• 4-5 years of experience in CSV validation or a similar field.
• Fluency in Italian and English is required.

Mansioni

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

Conoscenze

Italian

English

Formazione

Bachelor's or Master's degree in Engineering/CS/IT/Life Sciences/Pharmacy/Chemistry/Biotechnology

Strumenti

Microsoft Office Suite

Descrizione del lavoro

Productlife Group seeks an experienced CSV validation professional in Italy to plan, coordinate, and execute computerized system validation for client projects, ensuring compliance with GAMP 5, GMP, EU GMP Annex 11, and 21 CFR Part 11. You will manage validation documentation, perform risk assessments, and support regulatory inspections.

Ideal candidates have 4-5 years of experience, strong data integrity knowledge, and fluency in Italian and English.