Take your career to the next level with Amaris Consulting as a IT Validation Manager (Pharma) . Become part of an international team, thrive in a global group with €800M turnover and 1,000+ clients worldwide , and an agile environment by planning the kickoff and follow-up on projects. Join Amaris Consulting, where you can develop your potential and make a difference within the company.

✍️ WHAT WOULD YOU NEED?

• Degree in Business Administration, Computer Science , or comparable professional experience
• Around 4 years of experience proven experience in validation within a GxP-regulated environment , preferably in an IT area
• Strong knowledge of GAMP5 (v2) principles and their practical application
• Ability to quickly learn and manage system lifecycle documentation (e.g. Validation Plan, URS, Functional Specifications, Risk Assessments, Test Reports, AAP, etc.)
• Experience in developing and delivering training on KBs and SOPs aligned with the Validation Plan and AAP
• Familiarity with ITIL v4 is considered an advantage
• Excellent written and spoken English
• Proven ability to work effectively in a virtual, international, and multicultural environment
• Strong organizational, analytical, and problem-solving skills , with a results-driven mindset
• Excellent communication, collaboration, and stakeholder management skills

WHAT WILL YOU DO?

• Ensure that all validation activities are properly planned and executed in accordance with validation strategies, GxP requirements , and applicable SOPs prior to system go-live
• Maintain the validated state of the system throughout its entire lifecycle
• Collaborate closely with Quality Assurance (QA) on compliance-related topics
• Coordinate with System Owners, Process Owners, Business Process Owners, System Leads, Developers , and other key stakeholders
• Ensure that all system-specific SOPs and System Lifecycle (SLC) documentation are in place before system operation
• Oversee testing activities , including review and approval of executed test cases
• Provide audit support and maintain up-to-date system documentation and presentations
• Manage and resolve system discrepancies in collaboration with global system roles
• Drive continuous improvement by optimizing and simplifying validation processes using risk-based approaches