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

Location: Parma, Italy

Salary: Minimum €52,000 annually, plus eligibility for an annual performance bonus.

Company

hirify.global is an international research-focused biopharmaceutical group operating in more than 30 countries, with headquarters in Parma, Italy, and more than 8,000 employees.

What you will do

• Coordinate and supervise computerized systems validation in GxP environments, including the impact of new digital technologies.
• Draft validation procedures, validation plans, validation summaries, and periodic validation reviews.
• Review and approve user requirements, functional specifications, qualification reports, software procedures, and SOPs.
• Manage software-related changes, deviations, CAPAs, and quality risk assessments.
• Participate as a technical validation expert in internal and external audits, supplier audits, and authority inspections.
• Promote training and awareness on CSV, data integrity, software validation procedures, and applicable regulations.

Requirements

• At least 5 years of experience in computerized systems validation within the pharmaceutical industry.
• Excellent knowledge of computer systems validation activities and data integrity principles.
• Good knowledge of European and U.S. quality regulations and pharmaceutical guidelines, including CFR 21 Part 11, EU GMP Annex 11, MHRA, WHO, ICH E6, and GAMP5 Second Edition.
• Good knowledge of risk management techniques.
• Fluent English required.

Nice to have

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

Culture & Benefits

• Purpose-driven culture focused on sustainable innovation, reliability, transparency, and ethical behavior.
• Comprehensive benefits package including pension, private medical insurance, wellbeing programs, and flexible benefits.
• Work-life balance initiatives, flexible working arrangements, remote work options, and tax assistance for foreign colleagues.
• Relocation support, professional development resources, and training opportunities.