Quick overview
SeniorityMid Senior
Work modeHybrid
LocationPlainfield, NJ, United States
Job description
Job Title: CSV Validation Consultant - Pharma
Location: Plainfield,NJ (Hybrid)
Experience: 10 years
Job Description:
- Experience in Computer System Validation (CSV) within the Pharmaceutical/Life Sciences industry.
- Strong knowledge of GxP, FDA 21 CFR Part 11, GAMP 5, and data integrity requirements.
- Experience preparing/reviewing URS, FRS, Risk Assessments, IQ/OQ/PQ, Validation Plans and Reports.
- Hands-on experience with validation of GxP computerized systems and related documentation.
- Knowledge of change control, deviation, CAPA, and SOPs.
- Experience working with QA/Validation teams and supporting audits/inspection readiness.
- Strong documentation and communication skills.
Email:
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