Description:

This role is responsible for conducting in-process and final product quality
analyses and inspections in strict compliance with established standards and
regulatory requirements within a global pharmaceutical manufacturing
setting. 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 monitoring and timely
escalation. Manufacturing process deviations and defects in finished goods are
identified, documented, and reported in accordance with Good 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:
* Perform in-process and final product quality analyses and inspections in
compliance with regulatory and internal standards

* Interpret and evaluate analytical results for accuracy and precision against
established specifications

* Operate measuring devices, testing equipment, and follow predetermined
methods to accept or reject products

* Test random samples of finished goods to verify conformance with quality
specifications

* Report manufacturing process deviations and defects in finished goods to
relevant stakeholders

* Identify ongoing quality issues and recommend preventive measures to avoid
potential production problems

* Maintain accurate and complete documentation of

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