CSV Validation Specialist — Data Integrity & Compliance

ProductLife Group; Firenze; In loco; EUR 35.000 - 45.000; Tempo pieno

Descrizione del lavoro

ProductLife Group is hiring for a Validation Specialist to plan, coordinate, and execute Computerized System and Software applications validation in line with GAMP 5, GMP, EU GMP Annex 11, and 21 CFR Part 11.

You will prepare validation documentation, support data integrity, and work with cross-functional teams to ensure timely, compliant project delivery across client sites. Fluency in Italian and English is required.

Competenze

• Bachelor’s or Master’s degree in Engineering, Computer Science, IT, Life Sciences, Pharmacy, Chemistry, Biotechnology, or related field.
• 4–5 years of experience in CSV validation or related GxP validation work.
• Fluent in Italian and English.

Mansioni

• Plan, coordinate, and execute CSV activities for client projects in line with GAMP 5 and EU GMP Annex 11.
• Prepare, review, and manage validation documentation (plans, IRQ/OQ/PQ, 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, and lifecycle activities for computerized systems.
• Collaborate with QA, IT, Engineering, Manufacturing, and Validation teams to deliver projects.
• Assess impact of software changes on validated systems and update SOPs/VMPs accordingly.
• Provide validation support during audits and regulatory inspections.

Conoscenze

GxP regulations

Validation lifecycle

SDLC

MS Office

Data integrity

Teamwork

Problem solving

Interpersonal skills

Customer management

Team management

Willing to travel

Formazione

Bachelor's or Master's degree in Engineering/IT/Life Sciences

Strumenti

Microsoft Office Suite

Descrizione del lavoro

ProductLife Group is hiring for a Validation Specialist to plan, coordinate, and execute Computerized System and Software applications validation in line with GAMP 5, GMP, EU GMP Annex 11, and 21 CFR Part 11.

You will prepare validation documentation, support data integrity, and work with cross-functional teams to ensure timely, compliant project delivery across client sites. Fluency in Italian and English is required.