Validation Lead

Posted 1 month ago

Mandatory Skills:

Should have at least 8+ years of playing a business role in Pharmaceutical Laboratory sites

  • Should have 2-3 years of solid experience in LABX Method Development
  • Should have 2-3 years of solid experience in LABX Workflow Creation
  • Should have experience deploying LABX software for a pharmaceutical manufacturing site
  • Also required to Act as Validation and Qualification Lead on a large laboratory remediation projects, with specific focus on Laboratory Standalone COTS systems & LabX (Mettler)
  • Mettler LabX deployment, method development and validation experience (end to end) – pH, balance, titrators, refractometers, melting point and density meters; 2+ years’ experience with LabX method development and validation.
  • Experience in authoring the Business SOPs, typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.
  • Experience in executing the qualification documents for LABX installation and performing UAT for end to end testing

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