Description

JOB 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 environment.
- Positive 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.

Education

QUALIFICATIONS

- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred

Experience:

- 1 year or more in 1 - 4 Years

Specialized Knowledge: Licenses:

📌 Officer, Quality Control (Kowdoor)
🏢 Amneal Pharmaceuticals
📍 Kowdoor