Senior Manager-Caliber LIMS Tech lead

3 weeks ago

mumbai, India SUN PHARMA Full time

Hi,

We are having an opening for Senior Manager-Caliber LIMS Tech lead at our Mumbai/ Baroda location.


Position: Senior Manager-Caliber LIMS Tech lead

Location: Mumbai/ Baroda

Company: Sun Pharmaceutical Industries Ltd.


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.


Educational Qualification : B.E./B.Tech., BCA/MCA

Experience : 10-12 ( Caliber LIMS)

Skills : Experience of LIMS Caliber Global Rollout/ Configuration.

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