Job Description

Department DetailsRole Summary1. 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.
9. Manufacturing data collection from the difference equipmentxc3x82's for process investigation/improvements
10.To prepare and review the protocols and technical reports as required
11. Learn and use the statistical data analysis software such as Minitab, JMP SAS and SIMCA
12. Work towards the implementation of MVDA and PAT as part of operation excellence
13. Perfrom data analysis and co-author CPV and OOT reports
Additional:
1. To follow Quality & Safety procedures in R&D, cGMP procedure and ensure the compliance
2. To prepare, review & revise the SOP, EOP, Annexure, PIN, TPL, TMO, RPT etc as and when required.
3. Enhance knowledge through reading literature, scientific journals and being update on recent pharma and biotechnology product development and manufacturing trends.
4. Responsible for good documentation practice and continuous practice and implementation of quality and EHS systems in lab individually and through the team.
5. Fulfil the training needs identified for effective execution of job function and continual update.Key Responsibilities1. 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.
9. Manufacturing data collection from the difference equipmentxc3x82's for process investigation/improvements
10.To prepare and review the protocols and technical reports as required
11. Learn and use the statistical data analysis software such as Minitab, JMP SAS and SIMCA
12. Work towards the implementation of MVDA and PAT as part of operation excellence
13. Perfrom data analysis and co-author CPV and OOT reports
Additional:
1. To follow Quality & Safety procedures in R&D, cGMP procedure and ensure the compliance
2. To prepare, review & revise the SOP, EOP, Annexure, PIN, TPL, TMO, RPT etc as and when required.
3. Enhance knowledge through reading literature, scientific journals and being update on recent pharma and biotechnology product development and manufacturing trends.
4. Responsible for good documentation practice and continuous practice and implementation of quality and EHS systems in lab individually and through the team.
5. Fulfil the training needs identified for effective execution of job function and continual update.Educational QualificationsRequired Education Qualification: B.Pharma
Required Experience: 2 - 4 years

Biocon