Executive – IT

Job Description

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 environment. 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

Competencies