Pratik Shewale
Pharmaceutical Analytical Chemist (M.Pharm) with over 2 years of experience specializing in Analytical Development Laboratories (ADL), method validation, and regulatory stability t
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About
Pharmaceutical Analytical Chemist (M.Pharm) with over 2 years of experience specializing in Analytical Development Laboratories (ADL), method validation, and regulatory stability testing. Proven track record in HPLC, GC, and wet chemistry under ICH guidelines and ALCOA+ data integrity standards. Skilled in optimizing testing workflows and managing compliance across API and formulation environments.
Experience
Officer – Analytical Development Laboratory (Formulation) - Acme Pharmaceuticals Pvt. Ltd. - Sola, Gujarat, India
(2025-12)
- Lead formulation testing for solid oral dosage forms, conducting assay, dissolution profiling, and content uniformity across multiple active projects.
- Execute analytical method validation in strict compliance with ICH Q2(R1) standards, ensuring technical accuracy and regulatory readiness.
- Perform routine stability sample testing while maintaining GMP-compliant ALCOA+ documentation across all electronic records
Officer – Analytical Development Laboratory (API) - Kopran Research Laboratories Limited - Mahad, Maharashtra, India
(2024-07 - 2025-12)
- Performed HPLC and GC analyses for Raw material Assays, Organic purity testing, and Impurity profiling for active pharmaceutical ingredients (APIs).
- Conducted Karl Fischer moisture determinations, pH calibrations, and Troubleshooting procedures to support routine batch release.
Education
Master of Pharmacy (M.Pharm) - Pharmaceutical Chemistry - MGV's Pharmacy College (2023)
Bachelor of Pharmacy (B.Pharm) - Ln Dr. JD Pawar College of Pharmacy (2020)
