Description

You will manage computer system and computerized equipment validation for local, global, and SaaS solutions.

Responsibilities

• Execute validation activities including requirements gathering, planning, design qualification, and test script execution.
• Perform system-based risk assessments to determine GxP applicability and associated validation requirements.
• Author and maintain validation documentation, including system descriptions, summary reports, and change qualification reports.
• Manage the ValGenesis electronic system, including template updates and end-user training.
• Conduct periodic reviews of computer systems and user access to ensure ongoing compliance.

Required Skills

• 5+ years of experience in GxP computer system validation with Cloud and SaaS solutions.
• Practical experience with quality risk management and risk-based validation approaches.
• Knowledge of cGMP regulations including 21 CFR Part 11 and Part 211, EuraLex Volume 4 Annex 11, and ICH Q7, Q8, Q9, Q10.
• Ability to perform change impact assessments and discrepancy management.
• Bachelor's degree in a Science or Engineering discipline.

Preferred Skills

• Experience with ValGenesis for validation lifecycle management.
• Experience validating systems supporting Clinical, Pharmacovigilance, Medical Affairs, Supply Chain, Regulatory Affairs, or Quality Assurance.

Key Skills

Education

Bachelor's degree