Lims Consultant

Cleanstep Pharma And Engineering Solutions

3 - 8 years

3 - 7 Lacs

pune

Posted:4 hours ago| Platform:

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Skills Required

caliber lims lims master data creation sample management test method data entry and validation crossfunctional team management gmp troubleshooting

Work Mode

Work from Office

Job Type

Full Time

Job Description

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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