Lims Consultant

4 weeks ago

Pune, India Cleanstep Pharma And Engineering Solutions Full time

Role & responsibilities

  • Review source documentation for master data objects such as laboratory methods and analysis
  • Create/ build master data objects in the LIMS, including test methods, specifications, sample plans, and instruments
  • Ensure data consistency, accuracy, and compliance with internal SOPs and external regulatory requirements (e.g., FDA, ISO, GxP)
  • Support LIMS validation activities, including documentation and testing.
  • Troubleshoot and resolve data-related issues within the LIMS
  • Collaborate with a team of master data builders working across various sites for the LIMS deployment

Preferred candidate profile

  • 2+ years of experience working with LIMS platforms (Ideally, Caliber)

  • Strong understanding of laboratory operations and data management principles

  • Experience with master data configuration for LIMS systems

  • Excellent attention to detail and problem-solving skills
  • Strong communication and collaboration abilities
  • Experience in a regulated industry (e.g., pharmaceuticals, biotech, food safety)
  • Knowledge of GxP, 21 CFR Part 11, and other regulatory frameworks
  • Bachelors degree in Life Sciences, Information Technology, or a related field

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