Description:

The position is responsible for in-process and final product quality
investigations in compliance with internal standards and global regulatory
requirements. The role focuses on interpreting analytical and microbiological
data for accuracy and precision against approved specifications.The role
involves identifying recurring quality issues, investigating OOS, OOT,
deviations, and trends, and preventing potential production and product quality
risks. The role audits and monitors manufacturing outputs using validated
methods, instruments, and predefined specifications to accept or reject
materials and finished goods. The role ensures robust documentation, regulatory
readiness, and continuous improvement, while supporting corrective and
preventive actions to enhance overall quality performance.

Essential Functions:

* Perform detailed QC investigations for OOS, OOT, deviations,



and atypical
results
* Interpret and evaluate in-process, finished product, and stability data
against specifications
* Review analytical data, audit trails, and laboratory documentation for data
integrity
* Identify ongoing and potential quality issues and recommend preventive
measures
* Execute root cause analysis and ensure timely CAPA implementation
* Audit and monitor QC outputs for compliance
* Support acceptance or rejection decisions for RM, PM, IP, and FG samples
* Ensure regulatory compliance with GMP, GLP, and pharmacopoeial requirements
* Trend quality data to detect systemic risks and process variability
* Support internal and external audits and inspections

📌 Assistant Manager, QC Investigation (India)
🏢 Amneal
📍 India