GxP CSV Validation Specialist – Regulatory Compliance

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

Vantaggi offerti da questo lavoro

Travel required

Descrizione del lavoro

Productlife Group in Italy is seeking an SDS Specialist – Autonomous Vehicle Diagnostics Calibration to lead CSV validation activities for client projects, ensuring compliance with GxP, GMP, EU GMP Annex 11, and 21 CFR Part 11. The role requires 4–5 years of experience, Italian and English language skills, and willingness to travel.

You will draft validation documentation, support audits, and collaborate across QA, IT, Engineering, Manufacturing, and Validation teams to deliver compliant

Competenze

• Knowledge of GxP regulations and GMP requirements for computerized systems.
• Experience with CSV lifecycle and validation methodologies.
• Understanding of SDLC and lifecycle management of computerized systems.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
• Italian and English language skills are mandatory.

Mansioni

• Plan, coordinate, and execute CSV activities for client projects compliant with GAMP 5, GMP, EU GMP Annex 11, and 21 CFR Part 11.
• Prepare and manage validation documentation including Validation Plans, IQ/OQ/PQ, and Validation Reports.
• Support data integrity and ALCOA+ principles in regulatory contexts.
• Assess software implementations' impact on validated systems and support lifecycle activities.
• Draft and update SOPs and Validation Master Plans; participate in internal and supplier audits.

Conoscenze

GxP regulations

GMP

GAMP 5

EU GMP Annex 11

21 CFR Part 11

CSV lifecycle

SDLC

MS Office

Regulatory compliance

Cross-functional collaboration

Formazione

Bachelor's or Master's degree in Engineering, Computer Science, Information Technology, Life Sciences, Pharmacy, Chemistry, Biotechnology

Strumenti

Validation documentation tools

Descrizione del lavoro

Productlife Group in Italy is seeking an SDS Specialist – Autonomous Vehicle Diagnostics Calibration to lead CSV validation activities for client projects, ensuring compliance with GxP, GMP, EU GMP Annex 11, and 21 CFR Part 11. The role requires 4–5 years of experience, Italian and English language skills, and willingness to travel.

You will draft validation documentation, support audits, and collaborate across QA, IT, Engineering, Manufacturing, and Validation teams to deliver compliant