Description:

The position is responsible for in-process and final product quality analyses and inspection in compliance with approved standards and regulatory requirements. The role involves interpreting and evaluating analytical results for accuracy and precision against established specifications. The role uses measuring devices, testing equipment, predefined methods, operations, setups, and specifications to support acceptance or rejection of materials and products. The position identifies ongoing quality issues, prevents potential production problems, and recommends improvements. The role audits, monitors, and determines the quality of manufacturing processes and outputs, performs random testing of finished goods, and reports manufacturing process deviations and product defects, ensuring data integrity, GMP compliance, and regulatory adherence.

Essential Functions:
Perform in-process and final product quality analyses and inspection
Execute Finished Product (FP) Testing and IP/FP Analytical Testing
Interpret analytical results for accuracy, precision, and compliance
Operate measuring devices, laboratory instruments, and testing equipment
Apply approved analytical methods, operations,



and specifications
Support acceptance or rejection decisions for materials and products
Identify ongoing quality issues and prevent production risks
Audit and monitor manufacturing processes and quality outputs
Conduct random sampling and testing of finished goods
Review and maintain GMP documentation and analytical records

Report manufacturing process deviations and product defects
Additional Responsibilities:
Participate in method validation, verification, and transfer activities as required.
Assist in updating and reviewing SOPs, specifications, and analytical procedures.
Contribute to continuous improvement initiatives in the QC department.
Report any out-of-specification (OOS) or out-of-trend (OOT) results promptly to the supervisor.
Support cross-functional departments such as QA, Production, and Regulatory Affairs as needed.

Education:
Bachelors Degree (BA/BS) B. Sc. - Required
Master Degree (MS/MA) M. Sc. - Preferred

Experience:
3 years or more in 3 - 6 Years

Specialized Knowledge: Licenses:

📌 Executive, Quality Control Dahej
🏢 Amneal Pharmaceuticals
📍 Dahej