Validation Specialist

Company

Karwell Technologies

Location

Wilson, North Carolina, United States

Type

Full-time

                Roles and Responsibilities:  

   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.  

   Preferred Qualifications  

   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.

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Validation Specialist

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