More jobs:
CSA Validation Subject Matter Expert; SME
Job in
Jamaica, Queens County, New York, 11435, USA
Listed on 2026-02-18
Listing for:
Saxon Global
Full Time
position Listed on 2026-02-18
Job specializations:
-
IT/Tech
Data Analyst, IT Consultant, Data Security, Systems Analyst
Job Description & How to Apply Below
Location: Jamaica
Key Responsibilities
- Provide expertise and insight on validation project risk assessment and complexity
. - Maintain validation best practices and ensure alignment with Good Documentation Practices (GDP).
- Gather project information from System Owners and collaborate with Business Analysts
. - Draft, review, and execute key validation deliverables, including:
- GxP Assessment
- Risk Assessment (RA)
- Validation Plan (VP)
- Test Plan (TP)
- Validation Summary Report (VSR)
- Collect feedback from stakeholders and ensure regulatory and data integrity compliance
. - Contribute to the development and review of additional validation documentation as needed.
- Support change management and maintain documentation according to GAMP 5 and 21 CFR Part 11 standards.
- Bachelor's Degree in Computer Science, IT, Chemical/Biomedical Engineering, or related field.
- 7-10+ years of progressive experience in Computer System Validation (CSV) and Computer Software Assurance (CSA).
- Strong understanding of GxP
, FDA regulations
, Data Integrity
, and ALCOA+ principles. - Hands-on experience in CAPA generation, review, and resolution
. - Strong communication, leadership, and collaboration skills.
- Experience working in Medical, Pharmaceutical, or Regulatory Compliance industries is required.
- Agile experience/knowledge is highly preferred
.
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