Description:

This role is responsible for conducting in-process and final product quality
analyses and inspections within a quality control laboratory in strict
compliance with established standards and regulatory requirements within a
global pharmaceutical manufacturing workplace. 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 laboratory 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 laboratory 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 sand stability quality analyses and
inspections within the QC laboratory in compliance with regulatory and
internal standards.
* To operate Instrument like Dissolution, UV and IR-Instruments.
* To perform the testing as per ALCOA
* Identify ongoing quality issues and recommend preventive measures to avoid
potential production problems

* Maintain accurate and complete documentation of all laboratory testing
activities in accordance with GDP and GMP requirements

Additional Responsibilities:

* Comply with all applicable EHS policies, SOPs, statutory requirements, and
use the prescribed

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