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