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KPG99 INC • Wilson, North Carolina, United States
Required Qualifications 5+ years of hands-on CSV in GxP environments. Experience with risk assessments, URS, IQ/OQ/PQ, deviations, reports. Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q9, ALCOA+. Experience with lab instrument software. Experience with CDS, LIMS and maj
Required Qualifications 5+ years of hands-on CSV in GxP environments. Experience with risk assessments, URS, IQ/OQ/PQ, deviations, reports. Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q9, ALCOA+. Experience with lab instrument software. Experience with CDS, LIMS and major vendor systems. Experience with Computer Software Assurance (CSA) principles. Experience with electronic testing tools (e.g. HPQC/ALM). GAMP or ASQ certifications. Degree in science or engineering.