Junior Team Member - Statistician

Division

Department

Sub Department 1

Job Purpose

Statistician Role shall be able to understand the problem and questions, articulate the problem in clear non-statistical terms, and propose useful data driven/alternative solutions by incurring no regulatory citation.

This role shall prepare/review of statistical assessment reports/justifications for manufacturing/product development/quality data such as APQR, CPV, stability and validation activities for Cipla-Global Sites. This role will allow to interact with cross functional teams across Cipla Global units in terms of utilising statistical thinking, methods and resources in addressing the issues by involving in trend evaluations/statistical justifications/assessment.

Key Accountabilities (1/6)

Providing Global level support

To Provide Statistical Support through preparation/review of statistical reports to all Cipla Global manufacturing sites

Life Cycle Management - Annual Product Quality Review

To provide statistical inputs when the process performance of the parameters shows low or inadequate performance across the units of the respective site

Assist unit APQR personnel to prepare Statistical analysis and graphs/trend in APQR reports for the respective site.

Key Accountabilities (2/6)

Implementation of New Statistical concepts

Implement new statistical concepts whenever required to overcome departures during validation batches of the products

Root Cause Analysis for Investigations

To involve and provide statistical Justification for deviations /OOT’s /OOS reports.

Key Accountabilities (3/6)

Establishment of Limits

To establish Alert Limits/ Frequency Limits/trend Limits as needed either for Critical Process Parameters or Environmental Monitoring data across all Cipla sites.

Trainings

Providing trainings internally on Basic Pharmaceutical Statistics, Statistical Process Monitoring, Shelf-life analysis to APQR/CPV team and Validation teams with live examples

Key Accountabilities (4/6)

DOE concepts during Equipment Qualification

Involve and Apply DOEs for new equipment /machine qualification at sites

Data Visualisation and Dashboard/Report Building

Creating and developing tools and process through data visualisation/reporting dashboard to improve quality and productivity within statistics function.

Key Accountabilities (5/6)

Key Accountabilities (6/6)

Major Challenges

Regulatory requirement to provide Scientific/statistical justification in all OOS/OOT’s /Deviations etc., by. Overcome by Implementing new statistical concepts across Cipla and in understanding CFT/stakeholder to support through statistical analysis for decision making. Different practices followed in units due to differences in facilities, dosage forms and customer requirements. Overcome by having system in place for implementation through centralized process & SOP.

Key Interactions (1/2)

Internal

Corporate Quality Assurance, Integrated Product Development, Regulatory Affairs, Development Quality Assurance, Technology Transfer and Manufacturing

Key Interactions (2/2)

External

All manufacturing Sites of CIPLA including Site- Manufacturing, Quality Assurance, Quality Control and Manufacturing Science & Technology Group in different geographies

Dimensions (1/2)

Completion of activities within timelines: Timely review of Annual product quality reports for low or adequate performance of the products and to review the process validation documents whenever it is required for the respective site.  Key principles to control confounding factors, statistical procedure and competence to apply and good understanding of process variability.

Implementing new Statistical concepts in APQR and CPV SOP’s in CIPLA, which help to monitor the worst-case product statistically by applying advanced statistical tools (in line with regulatory expectations)

Dimensions (2/2)

Key Decisions (1/2)

Decisions

Providing insights into the data to facilitate decision makers at site level.

Key Decisions (2/2)

Recommendations

Batch performance, unit performance and test method performance.  Resolution of investigation, method development for statistical analysis. 

Education Qualification

M.Sc., in Statistics/master’s in chemical Eng. or Other data/statistics relevant post graduate degree.

Relevant Work Experience

M.Sc., in Statistics/master’s in chemical Eng or Other data/statistics relevant post graduate degree with minimum 2-3 Years of Experience in application of statistical/data science/analytics tools in pharmaceutical industry especially in pharma manufacturing and development, desirable to have pharmaceutical industry experience.

Data Science, Analytics Visual Dashboards creation, Lean Six Sigma, Good Communication Skills, well versed with data analysis and statistical applications, troubleshooting during Pharma Manufacturing process.

Software applications required: MINITAB (experience compulsory), JMP, MS office, MS SharePoint, Power BI and Python/R or any other Statistical software.