CMO CSV Audit ConsultantVirtualVocations • Dorchester, Massachusetts, United States
CMO CSV Audit Consultant
VirtualVocations • Dorchester, Massachusetts, United States
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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)
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Cmo • Dorchester, Massachusetts, United States
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