CMO CSV Audit Consultant

A company is looking for a CMO and Manufacturing Site CSV Audit Consultant.

Key Responsibilities

Conduct Computerized System Validation (CSV) audits for Contract Manufacturing Organizations (CMOs) and internal manufacturing sites

Develop and manage CSV audit processes, procedures, and documentation

Ensure compliance with Risk-Based Validation and maintain comprehensive documentation for validation activities

Required Qualifications

Bachelor's degree in a scientific or engineering discipline

7+ years of experience in computer validation within Life Sciences or Healthcare industries

7+ years of GMP experience with GAMP 5 in risk-based CSV

Audit experience in at least two critical systems : MES, PCS, LIMS, EBR, or ERP

Experience in developing validation documentation and testing protocols (IQ / OQ / PQ / UAT)