Validation Specialist (Data And Compliance)

PLG; Scandicci; Hybrid; EUR 35,000 - 45,000; Full time

Job summary

ProductLife Group is hiring a Validation Specialist (Data and Compliance) to plan, coordinate, and execute CSV activities for client projects. You will ensure compliance with GAMP 5, GMP, EU GMP Annex 11, and 21 CFR Part 11, while preparing validation documentation and supporting Data Integrity under ALCOA+ principles.

You will work with QA, IT, Engineering, Manufacturing, QC and Validation teams to manage risk, change control, deviations, CAPAs, and lifecycle activities for computerized

Qualifications

• 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 validation/compliance or related field.
• Italian and English language proficiency.

Responsibilities

• 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 docs: VPs, RA, URS, IQ/OQ/PQ protocols, and Validation Reports.
• Support Data Integrity compliance per ALCOA+ principles and regulatory requirements.
• Assist in risk assessments to define validation strategies and regulatory compliance.
• Support Change Control, Deviations, CAPAs, periodic reviews, and lifecycle activities for computerized systems.
• Collaborate with QA, IT, Engineering, Manufacturing, QC, and Validation teams to deliver projects on time and within quality standards.
• Assess impact of software implementations and changes on validated systems.
• Draft/update SOPs and Validation Master Plans for client projects; assist during internal and supplier audits.

Skills

GxP regulations

GMP requirements

CSV lifecycle

SDLC

Microsoft Office

Attention to detail

Team collaboration

Problem solving

Interpersonal skills

Travel availability

Education

Bachelor's or Master's degree in Engineering or Life Sciences or related field

Tools

Microsoft Office Suite

Job description

## Validation Specialist (Data And Compliance)Apply: Hybrid: Scandicci Office: Full time: Posted 11 Days Ago: JR000036Make a meaningful impact on global healthcare — and grow your career while doing it. At ProductLife Group, you’ll join an innovative, forward‐thinking team operating across the world to shape the future of life sciences through expertise, collaboration, and purpose‐driven work.**Job Description :****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 Microsoft Office Suite (Word, Excel, PowerPoint). **Additional experience and/or skills:*** Attention to detail* Team working and proactivity* Problem solving* good Interpersonal skills* customer management* team management* availability to travel is mandatory Compensation range: €35000 - €45000The compensation range indicated in this job posting represents an estimated range for the position. The final remuneration will be determined based on the selected candidate’s experience, skills, qualifications, and internal compensation policies, in accordance with applicable EU and local pay transparency and pay equity requirements.