Anusha J
Executive at Apotex Research private limited
- Role
- Executive at Apotex India
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Anusha J
I am an experienced pharmaceutical professional with a Master’s degree in Biochemistry from St philomena\'s college, mysore and over 5 years 4 month of diverse experience in the pharmaceutical industry. Currently, I serve as an Executive at Apotex, where I contribute to multiple areas of pharmaceutical development, with a focus on stability studies, In process, Finished product and Raw material analysis. My career has spanned leading pharmaceutical companies, including Medreich private limited was given me a strong foundation in generic drug development. I have been involved in various stages of the drug product lifecycle, from formulation compatibility studies and analytical validations to technology transfer, process optimization, and regulatory documentation in alignment with international guidelines (ICH, USFDA, MHRA, WHO).*HPLC Expertise*: I am particularly skilled in High‑Performance Liquid Chromatography (HPLC), having independently managed: Method development and method validation for finished products, In process, Raw material and stability samples; Analysis of impurities, Assay and dissolution profiles; System suitability and column performance assessments; Routine and stability sample analysis across various dosage forms; Preparation of HPLC‑related documentation for audits and regulatory submissions. I have used multiple HPLC systems and software (e.g, Empower and Lab Solutions), and I’m confident in troubleshooting, optimizing chromatographic condition.*Analytical instrumentation Experience: Beyond HPLC. I have hands-on expertise in operating and calibrating a wide range of analytical instruments: UV-Visible Spectrophotometers, Dissolution Apparatus, Karl Fischer Titrator (for moisture content analysis), Partical size analyser by malvern, Analytical Balances and pH meters.I have in-depth knowledge of GMP (Good Manufacturing Practices) and QMS (Quality Management Systems), with experience supporting: Regulatory audits (USFDA, ANVISA, PMDA) Documentation control and data integrity practices as per ALCOA+ principles.Dosage Forms & Formulation Experience: Solid oral dosage forms (tablets, capsules)Professional Values: I am passionate about continuous learning, scientific innovation, and the mission to deliver high-quality, affordable medicines globally. Currently open to opportunities in global pharmaceutical R&D, analytical development, regulatory science, and quality systems roles across international locations.*Top skills*- Research Skills- Executive Services- Analytical Skills- Good Laboratory Practice (GLP)
Experience
Executive
Mar 2023 — Present · Bengaluru, IN
Education
University of Mysore
Masters of science , Biochemistry
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