Work from Office
Full Time
Test Lead - Embedded Software
Extensive validation experience in 21 CFR Part 11.
Good understanding of GxP standards.
Good Knowledge in Data Integrity
Well acquainted with all the phases of Validation Life Cycle (VLC).
Expertise in planning and execution of Validation Master Plan, requirements gathering (User Requirement Specifications), QRA.
Extensive experience in creating, reviewing and executing test protocols (Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)), Traceability Matrix and Validation Summary Report (VSR).
Expertise in technical writing and reviewing of Standard Operating Procedures (SOPs), Work Instructions.
Excellent knowledge and good working experience in executing Gap Analysis, and Change Control Process.
Extensive experience in performing Risk Assessment.
Good communication skills and English fluency.
Lab equipments knowledge
HCLTech
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