Shailja Kaur

Background

About Shailja Kaur

I am a Pharmaceutical professional with 7 years of experience as an Analytical Chemist. I have worked at Johnson & Johnson Limited for 5 years. It groomed me as a Scientist for the strict dedication towards high GMP/GLP/Compliance/Safety and Regulatory Requirements of the pharmaceutical industry. I was exposed to the Global standards and technologies. I was working mainly in QC Lab performing Registration stability studies from start to end for a number of drug candidates. I received Encore Award for Stability Study, Stability Data compilation and Release of Clinical Batches for Antiviral Drug. In addition, I was responsible of Analytical Lab maintenance, calibrating lab instrument, investigating for calibration failures or OOS/OOT results obtained during drug testing, Data review, Initiating and Coordinating lab events/deviations/CAPA. I have been appreciated and regularly rewarded for my Analytical work. I got some exposure in Method Development and Validation team where I was responsible for developing new methods for DS and DP. I prepared Method Validation/Transfer Protocols/Reports. My Skills are- Sample Preparation/Registration Stability Study/ Release Testing of Raw Materials, API and Finished Products/Method Development / Validation / Method Transfer / Wet Chemistry / Data Review/ Quality and Compliance/ Writing SOPs/Test Methods/ Reports/Instrument Calibration/ Investigations for issues in drugs eg- OOS, OOT, unknown peaks/Initiating Lab events / Deviations / CAPA /GMP / GLP / Integrity / Safety / ICH Guidelines. Techniques- HPLC/UPLC/LC-MS/Dissolution/ KF Analysis/IR Spectrophotometer/ UV-Vis Spectrophotometer. Software- Microsoft Word/ Microsoft Excel/ Empower/Masslynx/Chemstation/Tiamo/ LIMS/e-labnotebook. Other Skills- Manual dexterity/Attention to detail/Organizing and Prioritizing tasks/Ability to work in fast paced environment/communication skills with different departments, teams, customers and stakeholders.