Description:

This role is responsible for conducting in-process and final product quality
testing and analyses in strict compliance with established standards and
regulatory requirements within a global pharmaceutical manufacturing
environment. The incumbent interprets and evaluates analytical results in terms
of accuracy and precision against predefined specifications to ensure product
integrity. Various measuring devices, testing equipment, and predetermined
methods are employed to accept or reject products based on prescribed
specifications. The role contributes to identifying ongoing quality issues and
preventing potential production problems through proactive testing and timely
escalation. Testing and reported in accordance with Valuable Manufacturing
Practices. Random samples of finished goods are tested to verify conformance
with internal and regulatory quality standards. The position supports continuous
improvement initiatives by suggesting enhancements to testing methods and
quality processes. It operates within a structured quality management framework




aligned with 21 CFR Part 210 and 211, ICH guidelines, and applicable Indian and
international pharmaceutical regulations.

Essential Functions:

* Maintain media stock and reconcile records of media used in analysis.
* Perform water sampling and analysis following defined SOPs/protocols and
ensure proper documentation.
* Report and log OOS (Out of Specification), OOT (Out of Trend), and EM
(Environmental Monitoring) excursions.
* Conduct environmental monitoring of the laboratory.
* Perform analytical validation, culture maintenance, and growth promotion
testing (GPT) of media; record observations and generate reports.

* Carry out microbiology laboratory tests such as Bioburden Analysis, MLT
(Microbial Limit Test), Sterility Testing, BET (Bacterial Endotoxin Test),
etc., in compliance with approved procedures.

* Skills and Proficiency:

* Microbiology Instrumentation Handling – Expert
* Good Laboratory Practi

📌 Officer, Quality Control Testing (Sanand)
🏢 Amneal India
📍 Sanand