Qualification & Validation Specialist

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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, ensuring our cloud infrastructure meets regulatory compliance standards such as GxP, HIPAA, and ISO 27001.

• Lead and develop IQ/OQ/PQ documentation for AWS infrastructure components.
• Collaborate with Dev Ops and Cloud Engineering teams to understand architecture and deployment models.
• Ensure infrastructure is validated according to GAMP 5 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 (e.g., 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.

• Bachelor's degree in Computer Science, Information Systems, or related field.
• 5+ years of experience in cloud infrastructure, preferably AWS.
• 3+ years in validation or compliance documentation in regulated industries.
• Strong understanding of AWS services: EC2, S3, RDS, IAM, VPC, Cloud Trail, Cloud Watch.
• Experience with Infrastructure as Code (IaC) tools:
  Terraform, Cloud Formation.
• Familiarity with GxP, GAMP 5, HIPAA, or ISO 27001 compliance frameworks.
• Excellent written communication and documentation skills.
• Experience with audit processes and regulatory inspections.

Mid-Senior level

Full-time

Quality Assurance

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