Job Purpose: To manage Caliber LIMS operations, master data, and laboratory workflows while ensuring data integrity, GMP compliance, and effective functioning of QC activities.

Key Responsibilities
• Operate and maintain Caliber LIMS for routine QC laboratory activities.
• Create and maintain master data, including Products, Materials, Specifications, Worksheets, Tests, Test Plans, TDTCs, and COAs.
• Perform sample login, registration, tracking, and verification of specifications and test plans.
• Troubleshoot LIMS issues and coordinate with vendors, IT, and corporate support teams for resolution.
• Ensure accuracy, completeness, traceability, and integrity of LIMS master data and laboratory records.
• Support change controls, SOP revisions, master modifications, system validation, and audit-related activities.
• Coordinate with QC, QA, Production, and IT teams for LIMS-related requirements.
• Participate in investigations,



discrepancy handling, and CAPA activities related to LIMS.
• Ensure compliance with cGMP, ALCOA+, data integrity requirements, and company procedures.
• Provide user support and training while ensuring timely completion of LIMS transactions. Educational Qualification: B.
Pharm / M.
Pharm / B.
Sc. / M.
Sc. in Chemistry, Analytical Chemistry, or a relevant scientific discipline.

Experience:
Relevant experience in Caliber LIMS operations within the pharmaceutical industry. Experience in injectable manufacturing is preferred. Required Skills
• Hands-on experience in Caliber LIMS operations and master data management.
• Knowledge of QC laboratory workflows, GMP, and ALCOA+ principles.
• Good troubleshooting, documentation, and coordination skills.

📌 Quality Control Executive (Sanand)
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