Description

Perform analysis of Raw Materials, In-Process Samples, Intermediates, Finished Products, and Stability Samples as per approved specifications and test methods.

Conduct wet chemical tests such as Assay, pH, Loss on Drying (LOD), Water Content, Residue on Ignition, and other pharmacopeial tests.

Prepare and standardize volumetric solutions, reagents, and buffer solutions.

Perform analysis of Raw Materials, Intermediates, Finished Products, and Stability Samples as per approved specifications and test methods.

Conduct wet laboratory tests including Assay, Related Substances, pH, Loss on Drying, Water Content, Residue on Ignition, and other pharmacopeial analyses.

Preparation and standardization of volumetric solutions, reagents, and buffers. PREFERRED CANDIDATE PROFILE Experience in a regulated API manufacturing facility.

Exposure to regulatory inspections and audit compliance activities.

Ability to work in shifts and meet testing timelines.

KEY RESPONSIBILITIES Perform analysis of Raw Materials, Intermediates, In-process Samples, Finished Products,



and Stability Samples as per approved specifications and test methods.

Carry out wet chemical testing including Assay, pH, Loss on Drying (LOD), Water Content, Residue on Ignition, and other routine analyses.

SKILLS REQUIRED Hands-on experience in Wet Laboratory testing within an API pharmaceutical workplace.

Good knowledge of pharmacopeial requirements (USP, BP, EP, IP).

Understanding of cGMP, GLP, GDP, and Data Integrity (ALCOA+) principles.

Proficiency in preparation and standardization of volumetric solutions, reagents, and buffers.

Experience in handling laboratory instruments such as UV-Visible Spectrophotometer, pH Meter, Karl Fischer Titrator, Analytical Balance, and Potentiometric Titrator. EDUCATIONAL QUALIFICATION M.Sc. (Chemistry/Analytical Chemistry/Organic Chemistry) / B.Pharm / M.Pharm Strong understanding of cGMP, GLP, GDP, and Data Integrity requirements.

📌 Officer, Quality Control (Visakhapatnam)
🏢 Amneal
📍 Visakhapatnam