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)
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
