Description

You will lead the configuration, testing, and implementation of Caliber LIMS workflows and modules within a GMP environment.

Responsibilities

• Configure, test, and implement Caliber LIMS modules and workflows.
• Lead testing, validation, and qualification activities for GxP applications in compliance with regulatory guidelines.
• Coordinate with cross-functional teams for requirement gathering and manage vendor activities regarding development, bug fixing, and builds.
• Manage the Quality Management System, including investigations, change control, incidents, deviations, and CAPA.
• Prepare and approve technical documentation, including administration procedures, validation documents, and DRP.
• Support sites during regulatory audits and provide technical training and hypercare support post-Go-Live.

Required Skills

• 10-12 years of experience specifically with Caliber LIMS.
• Proven experience in Caliber LIMS global rollouts and configuration.
• Deep knowledge of validation approaches for GxP applications in GMP environments.
• Ability to integrate instruments to fetch data from CDS and non-CDS sources.
• Proficiency in SQL or Oracle DB for executing queries, data generation, and troubleshooting.
• Experience with LIMS administration modules.
• Strong competence in MS Office (Word, Excel, PowerPoint).
• B.E./B.Tech., BCA, or MCA degree.

Key Skills

Education

B.E./B.Tech., BCA/MCA