Vacancy Description
Job Summary:
We are seeking a skilled professional to lead and execute Infrastructure Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for AWS-hosted environments.
This role is critical in ensuring our cloud infrastructure meets regulatory compliance standards (, GxP, HIPAA, ISO ) through robust validation and documentation practices. Roles & Responsibilities :
Develop and maintainIQ/OQ/PQ documentation for AWS infrastructure components.
Collaborate with DevOps and Cloud Engineering teams to understand architecture and deployment models.
Ensure infrastructure is validated according to GAMP and Computer System Validation (CSV) principles.
Create and manage traceability matrices, risk assessments, and validation plans.
Support internal and external audits by providing documentation and evidence of compliance.
Maintain vers...