- Knowledge and experience to update product specification as per regulatory requirement in LIMS.
- Able to run impact analysis for updated specification and or product.
- Strong knowledge of cGMP, GLP and FDA related regulations and guidelines including 21 CFR part 11.
- Participate in System configuration & evaluations of Test case for the end user.
- Responsible for administration of LIMS supporting manufacturing and laboratory operations.
- Run-Manage Instruments & reference standard for laboratory use in LIMS software.
- Help to keep up-to-date inventory system in LIMS software.
- Led the design of chemical experiments resulting as a listed author in “Chemical Removal of Total Phosphorus from Wastewater to Low Levels”.
- Statistically proved that one measuring technique provided greater accuracy and precision then the standard procedure.
- Wrote the standard operating procedure for colorimetric analysis.
- Responsible for activities related to Analytical development & Cleaning validation projects.
- Work involved microbiological limit test of Antibiotics, Vitamins, Food and Water as per Indian pharmacopeia, British pharmacopeia, USP & other specifications.
- Maintenance and preservation of cultures, writing analytical reports.
- Antibiotic and Vitamin Assays, using Bioassay.
- Sterility testing of laboratory instruments.
- To carry out Mineral and Vitamin testing for determining Assay (titrimetric/ spectroscopic), pH, Moisture content, specific element content, water content, Identification test, specific optical rotation, Melting point.
- To carry out Analytical testing of food samples such as Moisture, Ash, Protein, Fat.
- Responsible for operation and calibration of UV spectrophotometer, Polari meter, pH meter, Moisture meter, Analytical balance, Melting point, Kjeltec, KF.
- Preparation and standardization of volumetric solutions
- Sample preparation and splitting for crude moisture and further processing.
- Used wet chemistry techniques to digest samples for mineral analysis.
- Used Kjeldahl method for protein analysis.
- Demonstrated responsibility and punctuality and was given the task of opening the lab and turning on the equipment that needed to warm up for use in the day.