Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Job Description (JD):
- For a role focused on Infrastructure Qualification and Validation Documentation for AWS tailored for regulated environments like pharma, biotech, or any GxP-compliant organization.
- 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 (e.g., GxP, HIPAA, ISO 27001) through robust validation and documentation practices.
Responsibilities:
- Develop and maintain IQ/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 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.
Requirements:
- 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, CloudTrail, CloudWatch.
- Experience with Infrastructure as Code (IaC) tools: Terraform, CloudFormation.
- Familiarity with GxP, GAMP 5, HIPAA, or ISO 27001 compliance frameworks.
- Excellent written communication and documentation skills.
- Experience with audit processes and regulatory inspections.