ASSOCIATE MANAGER

Department Details

Role Summary

1. Monitoring and analysis of manufacturing data. 2. Data analysis and coordination of the execution of experiments aimed at improving process robustness/productivity and determining root causes for process deviations, OOT investigations and OOS, change in raw materials (grade, vendor), to support process changes, supporting process characterization (if required). 3. Author/ review Root cause investigations for upstream process deviations. 4. Authoring/ review protocol and technical reports to support process changes, modifications, improvements and scale up to support implementation at manufacturing scale. Authoring study protocols and reports for any trials to support the same. 5. Investigations of process deviations and preparing investigation report for the same with suitable CAPA. 6. Authoring/ review Process Validation protocol and report. 7. Authoring/ review Hold time Validation protocol and report. 8. Perform scale down experiments to support process deviations or other associated activities. 9. Provide support for cross functional technical teams for large scale improvement, engineering and compliance related initiatives. 10. Monitoring the critical process operations on the shop floor.

Key Responsibilities

1. Monitoring and analysis of manufacturing data. 2. Data analysis and coordination of the execution of experiments aimed at improving process robustness/productivity and determining root causes for process deviations, OOT investigations and OOS, change in raw materials (grade, vendor), to support process changes, supporting process characterization (if required). 3. Author/ review Root cause investigations for upstream process deviations. 4. Authoring/ review protocol and technical reports to support process changes, modifications, improvements and scale up to support implementation at manufacturing scale. Authoring study protocols and reports for any trials to support the same. 5. Investigations of process deviations and preparing investigation report for the same with suitable CAPA. 6. Authoring/ review Process Validation protocol and report. 7. Authoring/ review Hold time Validation protocol and report. 8. Perform scale down experiments to support process deviations or other associated activities. 9. Provide support for cross functional technical teams for large scale improvement, engineering and compliance related initiatives. 10. Monitoring the critical process operations on the shop floor.

Educational Qualifications

Required Education Qualification: B.Sc
Required Experience: 10 - 12 years