Quality Control Analyst

1. To handle Analytical Method Transfer. 

1. Analytical Method Validation of assay and related substances, dissolution in drug and drug substances by HPLC & GC method.

1. Audit arrangements and readiness. 

1. To work according to working standard, inhouse reference standard, official pharmacopeia standards, and impurity standard maintenance.

1. To work in accordance with cGMP, and pharmacopeia and regulatory requirements for testing and validation procedures.

1. To handle analytical instruments like HPLC, GC, TLC, dissolution apparatus, FTIR, UV-VIS spectrometer, and KF coulometer, wet chemistry techniques. 

1. To handle method, transfer units, prepare review, and 

1. To follow Transfer Analytical proceduresand protocols

1. Performs any other related duties as assigned by Supervisors. 

Competencies: 

1. Industry Knowledge - Relevant experience in the regulated pharmaceutical industry, specifically Quality Control.

1. Health authority inspections and third-party audits. 

1. Understanding of manufacturing processes and / or quality systems element.

1. Problem Solving