GxP QA: CSV & MES Validation Expert

Compliance Group Inc; Sanford (NC); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

Compliance Group Inc. is seeking an experienced QA CSV / MES Validation Specialist to provide independent quality oversight for CSV and MES/EBR systems.

You will work with Validation, Manufacturing, IT, and project teams to ensure all validation activities comply with GxP, data integrity, and site requirements. The role involves reviewing validation plans, URS, IOQ/PQ, RTM, deviations, and the VSR, and ensuring inspection-ready documentation.

Qualifications

• Experience in a GxP pharmaceutical/biotech environment.
• Quality oversight for CSV projects.
• Experience with MES/EBR implementations preferred.
• Knowledge of GAMP 5 and risk-based validation.
• Working knowledge of 21 CFR Part 11, data integrity, and audit trails.
• Experience reviewing validation lifecycle docs (PVP, URS, IOQ/PQ, RTM, VSR).
• Strong CAPA, change control, deviation management background.

Responsabilités

• Provide QA review and approval of CSV deliverables during MES/EBR implementation.
• Review Project Validation Plan, URS, Risk Assessments, and RTM.
• Review IOQ/PQ protocols, test scripts, and validation documentation.
• Review and approve validation deviations, investigations, CAPAs, and retesting.
• Ensure documentation is complete, traceable, and inspection-ready.
• Approve Validation Summary Report and conclusions.
• Provide quality oversight of risk-based validation decisions and testing strategies.
• Support change control, system release, and go-live readiness.
• Collaborate with Validation, Manufacturing, IT and SMEs to resolve issues.
• Ensure final validation package meets GxP and site Quality standards.

Connaissances

QA / Quality Systems

Quality oversight

CSV validation

MES / EBR implementations

GAMP 5

21 CFR Part 11

Data integrity

Audit trails

CAPA

Change control

Deviations & investigations

Description du poste

Compliance Group Inc. is seeking an experienced QA CSV / MES Validation Specialist to provide independent quality oversight for CSV and MES/EBR systems.

You will work with Validation, Manufacturing, IT, and project teams to ensure all validation activities comply with GxP, data integrity, and site requirements. The role involves reviewing validation plans, URS, IOQ/PQ, RTM, deviations, and the VSR, and ensuring inspection-ready documentation.