Global R&D QA, Senior Validation, Digital & Data Integrity Specialist (Pharma)

Location: Must be based in or able to work from Parma, Italy (Hybrid/Remote options available)

Salary: From €52,000

Company

hirify.global is an international research-focused biopharmaceutical group with 90 years of experience, dedicated to promoting a healthier world through sustainable innovation.

What you will do

• Coordinate and supervise the validation of computerized systems in GxP environments.
• Draft and review validation plans, functional specifications, and qualification reports.
• Manage changes, deviations, and CAPAs related to software systems.
• Participate as a technical expert in internal and external audits.
• Act as the CSV point of contact during authority inspections.
• Support risk management activities for software quality aspects.

Requirements

• At least 5 years of experience in CSV within the pharmaceutical industry.
• Excellent knowledge of Computer Systems Validation activities.
• Strong understanding of European and U.S. quality regulations (CFR 21 Part 11, EU GMP Annex 11, GAMP5).
• Excellent understanding of Data Integrity principles.
• Fluent English required.

Nice to have

• Experience in CSV in clinical development.
• Knowledge of ICH E6 guidelines.

Culture & Benefits

• Comprehensive healthcare programs and wellbeing initiatives.
• Annual bonus scheme based on performance.
• Flexible working arrangements and remote work options.
• Robust relocation support for foreign colleagues.
• Access to continuous training and professional development.