IT Compliance Officer

Responsibilities

• ▹Validating, testing and documenting existing and upcoming software systems
• ▹Ensuring IT compliance with GxP and data integrity requirements for software-supported systems
• ▹Validating, testing and reviewing laboratory and enterprise management software
• ▹Performing regular reviews and handling deviations found in validations
• ▹Supporting change control for validated systems
• ▹Tracking the regulatory environment relevant to validation
• ▹Applying data integrity guidelines (EU GxP, FDA, MHRA) during software validation

Requirements

• ▹Relevant higher education degree
• ▹Knowledge of GAMP 5, GxP and pharmaceutical industry requirements
• ▹Knowledge of software testing/validation regulations and Data Integrity guides
• ▹Intermediate English, mainly for written communication
• ▹Familiarity with software testing and development phases
• ▹Analytical mindset, strong drive for professional development
• ▹Openness to a fixed-term position

Nice to have

• ▹Knowledge of 21 CFR Part 11 and EU GMP Annex 11, pharmaceutical industry experience

Soft skills

What we offer

• ▹13th-month bonus
• ▹Broad cafeteria benefits package
• ▹Private health insurance
• ▹Home office option
• ▹Company holiday resort on Lake Balaton
• ▹On-site medical services (dentistry, dermatology, etc.)
• ▹Company kindergarten and nursery
• ▹Sports and recreational activities
• ▹Group life and accident insurance

About the company

One of the leading generic pharmaceutical companies in Hungary and Central-Eastern Europe, covering the full pharmaceutical value chain from R&D to sales.