Pratik Shewale

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.

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.

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)