VDart Inc
Atlanta, GA
Post Resume to
View Contact Details &
Apply for Job
Job Description :
Validation Lead Essential Duties and Responsibilities:

· Prioritize and coordinate the daily activities of the Validation Engineers and Technicians/Validation contractors.
· Develop validation protocols to support the qualification/validation of equipment, processes and facilities (e.g.IQ, OQ
and PQ protocols, Operational SOPs Change Controls, User/Functional/Design Specifications, etc
· Generate and execute all Validation protocols (IQ/OQ/PQ) of all site equipment including production equipment,
utilities as applicable) and other related systems in a FDA regulated environment.
· Initiate and execute Corrective and Preventative Actions (CAPA) as required and / or contributing to/supporting
CAPAs as needed to resolve deviations resulting from qualification studies
· Update and maintain Validation Master Plans, Validation Plans, Validation Protocols, Qualification Program SOPs,
forms, records to meet cGMPs and federal regulatory requirements.
· Experience/understanding of cGMP, ICH Q9 Quality Risk Management is desired.