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Computer system validation (pharma)

León
Amaris Consulting
Publicada el 14 marzo
Descripción

Take your career to the next level with Amaris Consulting as a Validation Specialist (Test QA). 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? ✍️

* +3 years of senior experience in IT validation within GxP environments
* Proven expertise in Veeva Conformance and Validation Testing and W3C Validation
* Strong knowledge of pharma industry regulations and GxP compliance
* Experience with LeVA system life cycle documentation (VP, URS, FS, RA, Testing Reports, AAP)
* Degree in Business Administration, Computer Science or comparable professional experience
* English fluency and Spanish as mother tongue is highly valued


WHAT WILL YOU DO?

* Lead validation activities for global testing applications (BI-AS-ODIN, BI-IT-INMATION)
* Ensure compliance with validation planning and applicable BI standards before system operation
* Develop and maintain system-specific SOPs and SLC documentation
* Manage validation status throughout system lifecycle and post-operation phases
* Create and deliver training on Standard Operating Procedures as defined in Validation Plans
* Coordinate with IT Operations & Laboratories teams on Manufacturing Connectivity projects

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