Senior Team Member - COE Statistician

Division

Quality

Department

Corporate Quality Assurance

Sub Department 1

Quality Complaince and Sustainability

Location

Bangalore/Goa/Vikhroli

Job Purpose

Senior 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 will act as SME to manage junior statisticians and prepare/review of statistical justifications reports prepared by junior statisticians and approvals. This role shall also involve preparation/review/approval 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. In addition, the role may demand utilization of advanced tools/skills such as Analytics/AI/ML as per business requirements

Key Accountabilities (1/6)

• Providing Global level support

To Provide Statistical Support through preparation/review/approval 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 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

Mentor Junior statisticians and Innovate current approaches or methodologies using advanced AI/ML/Analytics tools as needed.

Software (Minitab) License user management and renewals within function

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

Additional Responsibilities (as needed)

Key Accountabilities (5/6)

• Additional Responsibilities (as needed)

Look for new and innovative statistical methodologies or opportunities for the benefit of Business/organisation

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)

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

Key Interactions (2/2)

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)

Responsible for monitoring 1-3 members supporting Oral Formulation Sites (approx. 20 sites across Globally with workload of approximately handling of 200-500 statistical assessments/reports annually)

Dimensions (2/2)

Key Decisions (1/2)

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

Key Decisions (2/2)

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

Education Qualification

M.Sc., in Statistics or Ph. D in Statistics or Masters/Ph.D in Engineering with Statistics Experience suitable with role.

Relevant Work Experience

M.Sc. in Statistics or Ph. D Statistics or Other Statistics Postgraduate suitable with role with minimum 6-9 Years of Experience in application of statistical/data tools in pharmaceutical industry especially in pharma manufacturing and product development with managing team of 2-3 people, must have pharmaceutical manufacturing industry experience only considered.

If Pharma experience criteria is meeting as stated above, Data Science/Analytics, Power BI, MS SharePoint/Power Apps, Lean Six Sigma Green/Black Belt and PQS-Culture of Excellence experiences will have added advantage.

Good Communication/management 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 Automate and Power Apps, PowerBI and Python/R or any other Statistical software.