CSV/CSA Expert (Pharmaceutical)

Location: Prague, Czechia

Company

hirify.global is an IT consultancy delivering software solutions across AI, ML, BI, web, automation, and regulated industry projects through fixed-price and time-and-materials models.

What you will do

• Lead and support the transition from traditional CSV to CSA practices.
• Define and implement risk-based validation and testing strategies aligned with regulatory requirements.
• Promote CSA principles across Configuration, Integration, QA, and delivery teams.
• Support validation of cloud-based and SaaS platforms in GxP environments.
• Align risk assessments with QA and automated testing strategies and coverage.
• Advise on regulatory requirements, support inspections and audits as a CSV/CSA SME, and drive organisational change.

Requirements

• At least 5 years of experience.
• Experience in Computer System Validation, including leading or supporting the transition to Computer Software Assurance.
• Knowledge of GAMP 5 2nd Edition, FDA CSA guidance, 21 CFR Part 11, and EU Annex 11.
• Experience developing and implementing risk-based validation and testing strategies in regulated environments.
• Experience validating cloud-based and SaaS platforms within GxP environments.
• Understanding of quality, compliance, and software testing processes.
• Experience aligning risk-based assessments with automated test coverage in collaboration with QA and Test Automation teams.
• Experience supporting regulatory inspections and audits as a validation SME.
• Strong stakeholder management, communication, influencing, and organisational change skills.

Nice to have

• Experience with Veeva Vault validation.
• Experience in pharmaceutical or life sciences environments.
• Experience introducing CSA methodologies across complex IT delivery organisations.

Culture & Benefits

• Freelance contract.
• Work on a pharmaceutical project within an IT consultancy environment.
• No degree required.