Senior Manager 2-Caliber LIMS

Areas Of Responsibility:

Shall configure, test and implement Caliber LIMS workflows and modules.

• Shall lead testing and implementation activities of LIMS.
• Coordination with CFTs for requirement gathering, requirement finalization.
• Shall coordinate with vendor for tracking development, testing, bug fixing and build finalization activity.
• Shall have knowledge of instrument integration to fetch details from CDS/Non CDS instruments.
• Shall be aware about administration module of LIMS Caliber. Shall have knowledge of SQL/Oracle DB to execute queries to generate customized data as well for troubleshooting purpose.
• To ensure that processes / workflows / modules are designed, prepared and executed as per the compliance requirements.
• Shall have through knowledge of validation approach for GxP applications as per regulatory guidelines and shall be able to lead validation activity for rollout of LIMS in GMP environment.
• To support for the timely execution and completion of qualification activities to Site users.
• To prepare, review/approve qualification scripts, and ensure test scripts execution activities as per approved script.
• To prepare, review and approve documents (Administration procedure, Validation documents, DRP etc.) related to project.
• To ensure support to business during hypercare and post hypercare of Go-Live of the application and resolve issues, if any.
• To monitor effectiveness check at the implemented sites. Identification of enhancements for process simplification, if any
• To ensure technical training / support for each site, whenever required.
• To escalate and discuss roadblocks / updates with stakeholders.
• To coordinate operational change management / test activities to ensure ongoing compliance with business and regulatory requirements.
• To update the issue tracker for the projects handled and support for closure of the issues.
• To handle the Quality management system and anticipating the investigation, initiate/ review, Impact assessment of change control, incidents, Deviations and CAPA.
• To ensure successful handover of the projects to their respective business owners, upon completion.
• Support sites during the regulatory audits and internal/ external audit observations.
• To have good hands on MS office (i.e. Word / Excel / Power Point) and other computer skills.

Job Requirements:

Educational Qualification : B.E./B.Tech., BCA/MCA
Specific Certification : NA
Skills : Experience of LIMS Caliber Global Rollout/ Configuration.
Experience : 10-12 ( Caliber LIMS)