Job Description

Department Details
Role Summary
1 Guide the team for statistical evaluation of comparability assessment and DS stability using different techniques such as tolerance interval, Mixed model ANOVA and confidence interval approach whenever required.
2 Guide the team for performing data trending and analysis for root cause investigation and CAPA identification for the deviations at manufacturing scale
3 Support manufacturing investigations and process improvements using data analysis and regression technique.
4 Guide the team to perform process monitoring of Manufacturing In-process data using Statistical process control charts (xbar, LJ and range charts) to visualize the performance of process over time and detect the onset of abnormal occurrences
5 To involve in technical discussions (Internal & CFT) and support the process related troubleshooting activities (at pilot and MFG scale) as and which required.
6 Identify the opportunities for establishing the platform for online manufacturing data retrieval , data modelling and predictive simulations.
7 To involve in comparability exercise, CPV, OOT reports and technical assessment reports.
8 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.

9 Support manufacturing excellence initiatives using data analysis as required
10 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.
11 Responsible for the usage of SIMCA software and for Multivariate data analysis and guide the team to perform analysis using SIMCA.
12 Preparation and review of reports such as CPV report, technical report, OOT report
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 Guide the team for statistical evaluation of comparability assessment and DS stability using different techniques such as tolerance interval, Mixed model ANOVA and confidence interval approach whenever required.
2 Guide the team for performing data trending and analysis for root cause investigation and CAPA identification for the deviations at manufacturing scale
3 Support manufacturing investigations and process improvements using data analysis and regression technique.
4 Guide the team to perform process monitoring of Manufacturing In-process data using Statistical process control charts (xbar, LJ and range charts) to visualize the performance of process over time and detect the onset of abnormal occurrences
5 To involve in technical discussions (Internal & CFT) and support the process related troubleshooting activities (at pilot and MFG scale) as and which required.
6 Identify the opportunities for establishing the platform for online manufacturing data retrieval , data modelling and predictive simulations.
7 To involve in comparability exercise, CPV, OOT reports and technical assessment reports.
8 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.

9 Support manufacturing excellence initiatives using data analysis as required
10 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.
11 Responsible for the usage of SIMCA software and for Multivariate data analysis and guide the team to perform analysis using SIMCA.
12 Preparation and review of reports such as CPV report, technical report, OOT report
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

Skills Required