SalaryNot Specified
Job Location Visakhapatnam,Andhra Pradesh,India


Statistical Expert Quality Process Validation Continuous Process Validation Pharma Regulations Statistical Certification
6 to 8 Years
Pharma / Biotech / Life Science
Functional Area

Job Title / Designation: Statistical Expert

Job Description:

Key Duties and Responsibilities:

  • Provide excellence in statistical support to the site and within the global network to drive the application of advanced and state-of-the-art statistical principles, tools and methodologies to improve process understanding, quality and compliance of the products, efficiency and capability of the processes and profitability of the organisation. 
  • Process Validation and Transfers: Statistical analysis of process validation data for demonstrating validity and equivalence
  • Execution of Continued Process Verification plan and implementation of statistical tool for trend analysis.
  • Ability to analyze results, handle deviations and provide risk based scientific justification for continued process verification, using statistical significant test results.
  • Trending analysis in the frame of Continuous Process Verification Implementation and application of Statistical Process Control principles, e.g. control charts, and other pattern recognition techniques. 
  • Support the compilation of Annual Product Review (APR)/Product Quality Reviews (PQRs). Facilitate and enable (multivariate) process monitoring and control principles, e.g. by Multivariate Data Analysis (MVDA). Review of stability data and definition of Internal Release Limits (IRL). 
  • Support critical root cause investigation (e.g. observation of Out of Spec (OOS) and other deviations): Support the analysis of complex data sets to facilitate Rapid Root Cause Investigation (rRCI) Accountable for providing meaningful statistical conclusions. 
  • Enable Process improvement initiatives also in alignment with operational excellence organization and methodologies e.g. IQP, Six Sigma, Lean Manufacturing: Capability and stability assessments Hypothesis Testing Models for facilitating process improvements, e.g. DoE, MVDA, Computational Fluid Dynamics (CFD), multi linear curve fitting etc.
  • Training: Enable the Site to have the necessary competencies in advanced applied statistical tools, cross functionally (MS&T, manufacturing, QA, QC, operational excellence, .) by designing and delivering training on available tools and how to use them in practice, providing ongoing coaching. Instruct how to collect (e.g. sampling plans which are statistically meaningful), set up and interpret data sets and statistical results highlighting constraints and limitations. Interacts with internal and external Reg bodies and Health Authorities, as well as internal functions.
  • Experience handling both biological and chemical processes preferred.
  • Certified in ASQ Six Sigma or equivalent certification demonstrating robust statistical knowledge mandatory


Minimum/Maximum/ Work Experience Required: 6 + years.

Location(s) of Job: Vishakhapatnam

Minimum Education Requirements: BSc Degree; Computer Science preferred.

No of rounds of Interviews: 2

Number of Vacancies: 1

Work Timings: 8 AM - 5 PM

Travel & Allowance: Covered by QIC; depending on project requirements

Languages: Hindi; English (Mandatory); Additional languages preferred as well.

Relocation & Reimbursement: Covered by QIC; Details to be agreed upon prior to start date

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