ASSISTANT MANAGER

Department Details

Role Summary

1 Support manufacturing investigations and process improvements using data analysis and regression technique. 2 Perform process monitoring of Manufacturing In-process data using Statistical process control charts to visualize the performance of process over time and detect the onset of abnormal occurrences 3 Statistical evaluation of DS stability using confidence interval and mixed mode ANOVA approach whenever required. 4 To involve in technical discussions (Internal & CFT) and support the process related troubleshooting activities (at pilot and MFG scale) as and which required. 5 Drafting and review of CPV protocol and CPV report. 6 Support to process and analytical development including; • Process comparability evaluation using Student T-test, Equivalence Test, Tolerance Interval, Confidence Interval etc. • DOE experimental planning and analysis. 7 Support manufacturing excellence initiatives using data analysis as required 8 Develop Predictive models between input and output of specific process by Multiple linear regression (MLR) which involves techniques like PCA and PLS using SIMCA and JMP. b) Additional (If Any) - Sl.No. Job Responsibilities 1 To follow Quality & Safety procedures in R&D and ensure the compliance 2 Involve in deviation closure by providing the technical supports and to be reviewer of change management initiated by manufacturing department. 3 To involve in technical discussions (Internal & CFT ) and support the process related troubleshooting activities ( at pilot and MFG scale ) as and which required. 4 To prepare, review & revise the SOP, EOP, Annexure, PIN, TPL, TMO, RPT etc as and which required.

Key Responsibilities

1 Support manufacturing investigations and process improvements using data analysis and regression technique. 2 Perform process monitoring of Manufacturing In-process data using Statistical process control charts to visualize the performance of process over time and detect the onset of abnormal occurrences 3 Statistical evaluation of DS stability using confidence interval and mixed mode ANOVA approach whenever required. 4 To involve in technical discussions (Internal & CFT) and support the process related troubleshooting activities (at pilot and MFG scale) as and which required. 5 Drafting and review of CPV protocol and CPV report. 6 Support to process and analytical development including; • Process comparability evaluation using Student T-test, Equivalence Test, Tolerance Interval, Confidence Interval etc. • DOE experimental planning and analysis. 7 Support manufacturing excellence initiatives using data analysis as required 8 Develop Predictive models between input and output of specific process by Multiple linear regression (MLR) which involves techniques like PCA and PLS using SIMCA and JMP. b) Additional (If Any) - Sl.No. Job Responsibilities 1 To follow Quality & Safety procedures in R&D and ensure the compliance 2 Involve in deviation closure by providing the technical supports and to be reviewer of change management initiated by manufacturing department. 3 To involve in technical discussions (Internal & CFT ) and support the process related troubleshooting activities ( at pilot and MFG scale ) as and which required. 4 To prepare, review & revise the SOP, EOP, Annexure, PIN, TPL, TMO, RPT etc as and which required.

Educational Qualifications

Required Education Qualification: Bsc
Required Experience: 1 - 5 years