Associate Analytical Scientist
Responsible for Evaluation, Revision, Modification, Creating of Testing Protocol and Method as per requirements.
- Responsible for Method Development and Validation of finished product, stability product as well as supporting testing and approving release product, reference material qualification, product development and MAD using of HPLC (TOTALCHROM), UPLC(CHEMSTATION), LIMS and UV-Spectrophotometer(CHEMSTATION), Colorimeter (DSC), PH meter, USP Dissolution Apparatus I & II, Auto sampler Dissolution Apparatus, Analytical Balance, Potentiometer, IR-Spectrophotometer, PSD Sonic Sifter, Karl fisher.
- Analyzing and interpreting validated and developmental Data using Compliance wire, CDMS, Track wise.
- Reporting and presenting reports and preparing product license documentation such as Protocol, Testing Method, Certificate of Analysis, summary report
- Managing onsite chemical inventory.
- Handling Routine laboratory Inspection and maintaining laboratories.
- Working by following Standard Operating System (SOP), EP, USP, FDA requirements and with Strong GDP, CGMP & CGLP, GxP environment and EHS standards.
- Working following Strong OSHA regulations for General Industry (OSHA 500)
- Working with ISO7/8 environment, FDA regulations.