Job Purpose:

To manage Caliber LIMS operations, master data, and laboratory workflows while ensuring data integrity, GMP compliance, and productive 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)
🏢 Emcure Pharmaceuticals
📍 Sanand