CSV Validation & Testing Lead Life Sciences
Katalyst Healthcares & Life Sciences
Validation And Testing Specialist
Provide validation and testing services to ensure system integrity, data accuracy, and regulatory compliance for Poseida integration initiatives. Support validation activities across QMS migration, archival systems, and reporting platforms within a regulated Life Sciences environment.
Roles And Responsibilities
- Validation & Testing
- Design, develop, and execute validation strategies, test plans, and test cases
- Perform functional, integration, and data validation testing for enterprise systems
- Validate Tableau reporting outputs and eArchive system integrations
- Verify metadata accuracy and completeness during QMS migration activities
- Ensure archival integrity, traceability, and compliance of migrated records
- Compliance & Data Integrity
- Support CSV (Computer System Validation) activities and documentation
- Ensure compliance with ALCOA+ data integrity principles and regulatory standards
- Assist in validation lifecycle activities including execution evidence and defect tracking
- Collaborate with QA and compliance teams to address validation findings and remediation activities
- Coordination & Reporting
- Work closely with business, QA, and technical teams during testing and validation cycles
- Prepare validation summaries, execution reports, and compliance documentation
- Support issue resolution, retesting, and final sign-off activities
Education & Experience
- 10+ years of experience in validation and testing within Life Sciences or regulated environments
- Strong experience in Clinical Data Validation and QMS validation processes
- Experience supporting CSV activities and regulatory compliance initiatives
- Knowledge of ALCOA+ principles, data integrity standards, and validation methodologies
- Hands-on experience validating Tableau reports and archival/eArchive systems
- Strong analytical, documentation, and stakeholder communication skills
- Experience with QMS migration and metadata validation
- Familiarity with Life Sciences compliance standards and GxP environments
- Exposure to enterprise archival systems and regulatory audit support
Vacancy posted 2 days ago
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