Associate - CQ

This job is with Pfizer, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Role Summary

Data analysis, statistical modelling, and data visualization of stability studies. Applying statistical methods to identify trends, interpret data, and support organizational objectives.

Key Responsibilities

Data analysis

• Conducting analytical similarity assessments for the products utilizing various statistical approaches, including Equivalence tests, Quality Range approaches.
• To extrapolate the available stability data till the shelf life of the established product and to find out the shelf life of the new products. Further, to perform the Shelf-life analysis for legacy products.
• To establish provisional trend limits based on the finished product data.
• To find out the root cause for Out of Trend or Out of Specification batches by considering the trend of respective product and then apply appropriate statistical tools.
• To perform statistical evaluation for the Out of Trend or Out of Specification batches to make a batch disposition decision.

Retention sample management

Stability management

GDP and GLP practices

Core Competencies

Standards, Processes & Policies

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control

Skills Required

Statistical Tools, Data Analysis, Cgmp, Data Visualization, Retention Management, Statistical Modelling