Test Lead - Embedded Software
Domain: Medical (must have)
Location: Bangalore 5 days WFO white field
Skill:
Experience in qualification of System(computer systems or Analytical instruments).
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
Good to have: Measurement system knowledge
Notice Period: 30 Days

Keyskills: 21 Cfr Part 11 equipment qualification test protocols Medical PQ Data Integrity OQ Validation Life Cycle IQ Gxp Standard Operating Procedures
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