A Operations 1 Daily Call Review and Handling Escalations e g Difference between Dates of call logged and Date of call resolved Problem Reported and Solution Provided Appropriateness Classification of Call category 2 Change Control Process Implementation e g No of changes occurred in setting No of RFC raised and RFC approved Date of change expected versus RFC initiated approved No of days taken to close the RFC post approval by CAB 3 Participating in Daily meetings Reporting and Taking Feedback from various department heads and Management 4 Operation Enhancement sustenance To find the root cause for the breakdown and taking the CAPA for the same e g Root Cause Analysis Preventive Action Document No of RCA-CAPA closed B Compliance 1 Asset Management Server Room Access Management Employee Entry-Exit process e g Observations Non-Compliance reported during audit 2 Backup Restore Management and Related Activity e g Observations Non-Compliance reported during audit 3 Compliance for Instrument connected machines e g No of NC received during Internal External Audit with reference to deletion of Data Copying of Data etc 4 IT Record Management and Kavach Related Coordination Role e g Observations Non-Compliance reported during audit 5 Validation Documentation for GMP GLP departments e g Observations Non-Compliance reported during audit 6 Ensure compliance to all cGMP GxP or any other regulatory requirements including EH S requirements C Projects 1 Managing expansion and upcoming changes in Plant Office e g Number of Projects undertaken and implemented No deviation from target implementation dates 2 Participating in Project Roll-out initiated from HO e g Number of Projects undertaken and implemented no deviation from target implementation dates no of users covered and time taken D Support 1 Handling PLC HPLC Instrument connected machines related Calls and coordinating with third Party Vendors e g Equipment downtime Internal Customer Feedback Time taken 2 Support and operation call related to WMS WnD DAS PLC Other Instrument connected software s e g Equipment down time Internal Customer Feedback Time taken log E Training 1 User Training e g new user Induction Quarterly training Training during change enhancement in technology No of trainings planned vs conducted No of users covered 2 FMS Team Management - Knowledge Transfer Attendance monitoring of members Identification of Key Technical resource e g Monthly report 3 Self-improvement - pre-defined mutually agreed as per Individual Development Plan Work Experience 10 Years work Experiance in Pharma IT Domain Hands on managing MFG equipments Education Graduation in Information Technology or Computer Science Competencies Result Orientation Collaboration Stakeholder Management Process Excellence Innovation Creativity Developing Talent Strategic Agility Customer Centricity
📌 Executive – It (Pune)
🏢 LUPIN
📍 Pune
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