CSV Consultant

Ex-J&J preferred Experience in the Pharmaceutical, biotechnology, or medical device industry 2+ years experience with System Development Lifecyle 3+ years experience in Computer System Validation (Based on the role selected) Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidances and industry standards (i.e., GAMP) Experience in writing and executing documentation for all aspects of the validation

Job Details: Ex-J&J preferred Experience in the Pharmaceutical, biotechnology, or medical device industry 2+ years experience with System Development Lifecyle 3+ years experience in Computer System Validation (Based on the role selected) Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance s and industry standards (i.e., GAMP) Experience in writing and executing documentation for all aspects of

Job Title: IM Regulatory Validation Lead Location: Raritan, NJ (Hybrid) Job Details: Experienced Validation lead to support end to end validation ownership of a Unified Regulatory Platform (URP) built on Veeva and AWS based cloud stack 8+ years experience in Computer System Validation or Quality management or Business Analysis in GxP application area Act as single point of accountability for validation deliverables, Responsible to Author Validation Deliverables which includes - Validation / Co

Responsibilities: Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments). Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans. Providing leadership, oversight, and training related to validation activities to multi-functional teams. Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentati