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Reference # : 17-00220 Title : Data Ingegrity
Location : Somerset, NJ
Position Type : Contract
Experience Level : Start Date : 06/01/2017  

Data Integrity Auditor

RCM audit practice seeks an CQA (certified quality) auditor to support data integrity auditing initiatives.
Must have demonstrable experience conducting audits and assessments and CAPAs. References required.

•Sr. level Quality management system remediation and data integrity remediation experience.
• Delivery of data integrity remediation plan, data integrity investigation protocol, retrospective evaluation, risk assessment, corrective action plan, interim measures, long term measures.
• System/software supplier qualification/auditing.

• Validation consulting and team leadership for major Pharma, Site VMPs, CSVMPs(computer systems validation master plans).
• Large and small scale remediation planning, execution, and reporting.

Strong in Validation, Software Test Manager, Global Project Manager, hands-on software implementer, MS Access advanced skills, EDMS, CDMS, EDC, 21 CFR 11, GxP Systems Auditor, EDI/B2B, Cloud Computing, Agile SCRUM, Waterfall Method