Qualification & Validation Specialist
Katalyst HealthCares & Life Sciences
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 version-controlled documentation repositories (, SharePoint, Confluence). Define and implement automated validation checks using tools like Chef InSpec or AWS Config. Stay updated with AWS service changes and assess their impact on validated environments. Education & Experience Bachelor's degree in Computer Science, Information Systems, or related field.
- years of experience in cloud infrastructure, preferably AWS.
- years in validation or compliance documentation in regulated industries.
Vacancy posted 1 day ago
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