27 Oct
|
Emcure Pharmaceuticals
|
India
27 Oct
Emcure Pharmaceuticals
India
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.
Positive troubleshooting, documentation, and coordination skills.
📌 Quality Control Executive Sanand (India)
🏢 Emcure Pharmaceuticals
📍 India