Sabir Azim
Analytical Specialist at Dr. Reddys Lab. Hyderabad, India. \"M.Pharma\" (Pharmaceutical Analysis), Jamia Hamdard. Ex Ranbaxy /Sun ll Ex Mankind Research
- Role
- Analytical Specialist at Dr. Reddy's Laboratories
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Sabir Azim
Strategic and results-driven Analytical Specialist with 14+ years of experience driving…
Experience
Analytical Specialist
Mar 2015 — Present · Hyderabad, IN
Analytical Method development, Method Validation for Assay, Related substance, Residual solvent, Dissolution and content uniformity of finished products like solid oral (Tablets, Capsules, suspension, solutions), Semisolid /Dermal products (Cream, Lotion, Gel, Ointment ), Injectables or Parenteral (Injections) and Nasal sprays by HPLC, GC, and UV. Method development & Validation for IVRT (In-Vitro release rate Testing) and IVPT (Skin studies) of Semisolids /Dermal products (Cream, lotion and gel) on diffusion cell (Hanson & Logan) apparatus. Method analysis of Spray characterization technique of spray products (Nasal spray). Knowledge of Method analysis on IVPT, Skin studies and IVRT testing of Semisolids.Technology transfer (Tech Transfer/Method transfer) skills: Technology Transfer (Method transfer /Tech Transfer) for different analytical methods for solid oral (Tablets, Capsules, suspension, solutions), Semisolid products (Cream, Lotion, Gel, Ointment), by HPLC, GC, UV and Diffusion cell (Hanson and Logan) in US-FDA approved Plants. Preparation of method development, Method Validation protocol and report for analytical methods and Preparation of Specifications and Standard Test Procedures (SOP/STP). Review of Analytical documentation/Data, Protocol, Report, COA and STP/SOP. Analytical method evaluation and Support/Routine and Stability analysis of Proprietary (Differentiated) and Generic products as per In-House STP, Pharmacopoeial (USP, EP, BP, IP and JP) method in comparison with innovator to certify the In-house products for ANDA and NDA filings in the US, Europe, Brazil, Russia or regulatory markets. Calibration and maintenance of analytical instruments like HPLC, GC, UV, Dissolution, Diffusion cell (Hanson and Logan). Analysis of Vitamins and Multivitamins drugs by HPLC, GC, UV and Ion Chromatography. Wet analysis like- Heavy metal test, Sulphated Ash, Loss of drying, Ash value & Titration.
Education
Jamia Hamdard
Bachelor's Degree, B.Pharma
2006 — 2010
Jamia Hamdard
M.PHARMA (Pharmaceutical Analysis), Pharmaceutical Sciences (Analytical Research and Development)
2010 — 2012
Skills
- Pharmaceutical Industry
- Research
- Gmp
- Validation
- Fundraising
- Regulatory Affairs
- R&D
- Pharmaceutics
- Hplc
- Dissolution
- Analytical Chemistry
- Sop
- Research and Development
- Karl Fisher
- Infrared Spectrometry
- Analytical Method Validation
- Method Development
- Titration
- Raw Materials
- Pharmaceuticals
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