Quality Control Executive

Emcure Pharmaceuticals Limited; Sanand; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Emcure Pharmaceuticals Limited seeks a Caliber LIMS Analyst to manage LIMS operations in a GMP environment. You will oversee master data, specifications, worksheets, tests and COAs, ensuring data integrity and traceability.

The role requires hands-on LIMS work and collaboration with QC, QA, Production and IT teams. Responsibilities include sample login, tracking, verification of test plans, and support for validation, change controls, and CAPA activities.

Qualifications

• Hands-on Caliber LIMS operations experience in pharma QC labs.
• Familiarity with GMP and ALCOA+ data integrity.
• Strong documentation and cross-functional coordination skills.

Responsibilities

• Operate and maintain Caliber LIMS for routine QC activities.
• Create and maintain master data including products, materials, specs, worksheets, tests, TDTCs and COAs.
• Perform sample login, registration, tracking and verification of specs and test plans.
• Troubleshoot LIMS issues and coordinate with IT, vendors and support teams.

Skills

Caliber LIMS operations

Master data management

QC laboratory workflows

GMP

ALCOA+

Troubleshooting & coordination

Documentation & training

Education

B.Pharm / M.Pharm / B.Sc. / M.Sc.

Tools

Caliber LIMS

Job description

Job Purpose:

To manage Caliber LIMS operations, master data, and laboratory workflows while ensuring data integrity, GMP compliance, and efficient 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.