· Perform Validation Assessment on customized and off-the-shelf
clinical trial data processing systems in compliance with the applicable
FDA Regulations that are 21CFRPart11 and 21CFRPart820.
Perform GxP Functional Risk
Assessment on customized clinical trial applications.
Author System Design and Master
Validation Plan documents for the customized applications.
Author User Requirement
Specifications (URS), Functional Requirement Specifications
(FRS), Installation Qualification (IQ), Operational Qualification (OQ) and
Performance Qualification (PQ)/ User Acceptance Testing (UAT), Traceability
Matrix, Deviation/ Exception reports and Validation Summary Report (VSR)
documents for the customized and off-the-shelf systems using a Validation
Lifecycle Management System (VLMS) software.
Periodic Review and Audit
Trail/ Data Integrity Review of different customized and third-party
systems to analyze any gaps or non-compliance with the regulations and
standard operating procedures.
Perform Root Cause Analysis for
Quality incidents and involved in the preparation of CAPA (Corrective
Action and Preventive Action) reports to ensure compliance with established
Create Test Plans and perform
functional and regression testing during various phases of test
lifecycle throughout the Defect Tracking and Resolution cycles.
Implement automation testing of
GxP computerized systems including identifying and implementing tools, setup of
testing, documentation, approval, and delivery.
Follow GAMP5 practices for authoring and reviewing Validation Documentation.
Support product innovation by
developing novel and creative software validation processes in an Agile
This position requires a minimum of a Bachelor’s
degree in Pharmaceutical Science or a combination of education and experience
equating to the U.S. equivalent of a bachelor’s degree in one of the