Senior Manager 2-Caliber LIMS

Job Description

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) Selection Process: Interested Candidates are mandatorily required to apply through the listing on Jigya. Only applications received through Jigya will be evaluated further. Shortlisted candidates may need to appear in an Online Assessment and/or a Technical Screening interview administered by Jigya, on behalf on Sun Pharma Candidates selected after the screening rounds will be processed further by Sun Pharma