Validation Expert

Consultant Digitalization of Customer Engagement (Life Sciences)

Tasks and responsibilities

• Ensure continuous, compliant operation of GxP-relevant computer systems under Managed Services.
• Lead and coordinate validation and re-validation efforts, maintaining audit‑ready lifecycle documentation.
• Support change management, upgrades, migrations, and decommissioning while preserving validation state.
• Provide ongoing compliance support aligned with 21 CFR Part 11, Part 820, EudraLex, and GAMP5.
• Collaborate with client IT, Quality, and Regulatory teams to align on validation and compliance actions.
• Standardize and reuse validation templates, protocols, and procedures across systems and clients.
• Monitor regulatory developments and adapt validation strategies accordingly.
• Integrate validation with service processes such as incident management, CAPA, and change control.
• Operate within ...