Executive, QA (Statistics)

Job Description

Title: Executive, QA (Statistics)

Company Name: US FDA Approved Leading Pharmaceuticals Company

Vacancy: --

Age: At most 30 years

Job Location: Gazipur

Salary: --

Experience:

Published: 2026-01-19

Application Deadline: 2026-01-30

Education:

• Bachelor of Science (BSc) in Statistics
• Master of Science (MSc) in Statistics

• Age At most 30 years

• Proficiency in speaking and writing both English and Bengali.

• Good computer knowledge.

• Must be able to work under pressure

• Conduct comprehensive statistical analyses for Process Validation and Annual Product Quality Review (APQR) to assess process consistency, robustness, and compliance with regulatory expectations.

• Perform Continuous Process Verification (CPV) analyses to monitor ongoing process performance and detect early signals of variability or drift.

• Execute trend analysis of stability study data to evaluate product shelf-life, identify degradation patterns, and support regulatory submissions.

• Perform OOT limit evaluations, with periodic revision of alert and action limits using statistically justified historical APQR data in compliance with regulatory expectations.

• Prepare and statistically evaluate Annual Environmental Monitoring Reports for the Sterile unit of manufacturing areas, ensuring microbiological and particulate control.

• Prepare Water System Summary Reports (monthly and annual), including trend evaluation and compliance assessment against pharmacopoeia and internal limits.

• Apply appropriate statistical tools and techniques (e.g., control charts, capability analysis, trend analysis) for process monitoring, tracking, and control, supporting continuous improvement and data-driven decision-making.