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Officer, Quality Control

Job Description - Officer, Quality Control

Description

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.


 



Qualifications
Education:
  • 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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