Associate - CQ

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.
  
  

• 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.
  
  

• 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• Withdrawn stability samples for the time frame and send samples to QC for testing.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.
  
  

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

• 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.
  
  

• 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.