Title:  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.