Officer, Quality Control

Amneal PharmaceuticalsIndia
Adzuna INPosted 4h agoOriginal Listing
scientific-qa-jobs

Job Description

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. - 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. Education QUALIFICATIONS - B. Pharm B. Pharm - Required - M. Pharm M. Pharm - Preferred Experience: - 1 year or more in 1 - 4 Years Specialized Knowledge: Licenses:

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