Role Purpose
To execute and technically support Quality Control laboratory activities by performing, reviewing, and coordinating analytical and microbiological testing in compliance with GMP to ensure product quality and timely release.
Role Description
- Perform and technically support chemical, biochemical, and microbiological testing for raw materials, intermediates, finished products, utilities, environmental monitoring, and stability samples in accordance with approved methods and GMP.
- Support analytical method transfer and method validation, including protocol execution, data generation, and documentation review.
- Operate and maintain QC laboratory instruments (chemical and microbiological), including supporting qualification, calibration, and routine performance checks.
- Review and verify test results, raw data, logbooks, and laboratory records for accuracy, completeness, and data integrity before escalation.
- Support investigation and documentation of OOS, OOT, deviations, and laboratory issues, and coordinate with QA, Production, and Engineering as required.