Validation Specialist
Pubblicato il 31-08-2026 - Productlife Group in Italia
Specific activities and responsibilities:
- Plan, coordinate, and execute Computerized System and SW applications Validation (CSV) activities for client projects in compliance with GAMP 5, GMP, EU GMP Annex 11, and 21 CFR Part 11 requirements.
- Prepare, review, and manage validation documentation, including Validation Plans, Risk Assessments, URS, IQ/OQ/PQ protocols, and Validation Reports.
- Support clients in ensuring Data Integrity compliance in accordance with ALCOA+ principles and applicable regulatory requirements.
- Perform risk assessments to define validation strategies and support regulatory compliance.
- Support Change Control, Deviations, CAPAs, periodic reviews, and validation lifecycle activities for computerized systems.
- Collaborate with cross-functional client teams (QA, IT, Engineering, Manufacturing, QC, and Validation) to deliver validation projects.
- Assess the impact of software implementations, upgrades, and changes on validated systems.
- Draft and update SOPs, Validation Master Plans (VMPs), and other GMP documentation for client projects.
- Provide validation and compliance support during internal audits, supplier audits, and regulatory inspections.
- Contribute to multiple client projects, ensuring delivery within agreed timelines, quality standards, and regulatory expectations.
Required education:
Bachelor's or Master's degree in Engineering, Computer Science, Information Technology, Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related field
Required experience :
4-5 years of experience
Required languages:
Italian and English
Required technical skills:
- 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 Micro