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

Education:

- B. Pharm B. Pharm - Required

- M. Pharm M. Pharm - Preferred

Experience:

- 10 years or more in 10 - 12 Years

Specialized Knowledge: Licenses:

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