Job Description

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

• Receiving and maintaining retention samples of raw materials, packaging materials and drug products.
• Monitoring of temperature in retention area as required.
• Ensure retention samples are stored under the recommended storage conditions.
• Issuance of samples as required.

Stability management

• Preparation of stability protocols.
• Loading stability samples as per the protocols and procedure.
• Withdrawn stability samples for the time frame and send samples to QC for testing.
• Compilation of stability data.

GDP and GLP practices

• To follow Good laboratory Practices.
• To follow Good Documentation Practices as per ALCOA principles.
• Follow 5S practices in CQ laboratory.

Core Competencies

• Expertise in handling statistical analysis.

• Expertise in handling stability management.
• Expertise in handling retention management.
• Knowledge of regulatory requirements, USP/EP and other pharmacopeia guidelines.

Standards, Processes & Policies

• Understanding of cGMP, GDP and GLP in Pharmaceutical Industry.
• Experience in the preparation of stability protocols, compilations, reports, and qualification protocols.
• Understanding SOP's, Specifications, test Procedure and other documents commonly used.

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