How you’ll spend your day
Maintaining a set of procedure supporting to ATS department for (GMP & GLP) techniques implementation.
Maintaining a system of methods and specification for all materials and products.
Analysis of stability samples & working standard qualification activity as per defined procedure & monograph.
Data filling and maintaining the logbooks, certificate, stability report and stability data in archive.
Monitoring of stability studies with respect to ICH Q-1 and conducting analytical method validation activity according to ICH Q-2.
To initiate the LIR / OOS if any procedural gap related with SOP / monograph during routine activity.
Qualifications of all analytical instruments should be maintained in stability Section.
Follow the defined safety procedure during day to day activity in laboratory.
Any other job assigned by Manager Quality Control.
Your experience and qualifications
Experience range should be minimum 3 – 4 Years
Should be Bsc/MSc
Good understanding of Quality Control, Understanding of GMP & GLP