Manager LIMS Project

Job Responsibilities:

To have thorough knowledge and understanding of QC workflows (Analysis/ Review/ Approve/ Investigation etc.), Analytical methods (Instrumental/ Pharmacopoeial chapters/ Monographs), QC instrumentation activities (operation, calibration, preventive maintenance etc.) and Analytical method validation/Method transfer activities and other processes of QC.

To have thorough knowledge and understanding of Analysis reporting requirements of all stages of product for e.g.; but not limited to; Finished product, API, Excipients, Process validation, Hold time, Swab/rinse samples, Stability including result reporting, trending, COA requirements etc.

To ensure that Processes / workflows / modules are designed, prepared and executed as per the compliance requirements.

To ensure that the tools and solutions can cater business requirements.

To conceptualize and frame a consolidated approach for Process/Workflow/ module finalization along with Site SPOCs related to application functionalities.

To support vendor for Technical discussion of requirements for finalization of application functionalities.

To perform functional testing with positive and negative challenge with logical program, as and when required.

To support for the timely execution and completion of qualification activities to Site users.

To prepare, review and approve qualification script, and ensure PQ execution activities as per approved script.

To prepare, review and approve documents (Governing SOPs, other Validation documents, BCP 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, review, Impact assessment of change control, incidents, OOS, OOT, 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.