HPLC/Analytical Testing: Perform Assay, Related Substances (RS), Impurity Profiling, and Content Uniformity testing on raw materials, in-process samples, finished injectable products, and stability samples using HPLC/UPLC.
Method Execution & Validation: Execute analytical methods as per pharmacopeia (USP, IP, BP) and in-house specifications. Participate in method validation, method verification, and transfer studies.
Instrument Handling: Operate and calibrate HPLC systems (Shimadzu/Agilent) with software like Lab Solutions or Empower.
Documentation & Compliance: Ensure all data is recorded accurately in accordance with GMP and ALCOA+ (Data Integrity) principles.
Troubleshooting & Investigation: Troubleshoot HPLC instruments and methods, identify OOS (Out of Specification) and OOT (Out of Trend) results, and support CAPA (Corrective and Preventive Actions).
Sample Prep: Prepare mobile phases, standards, and sample solutions for injection.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: OtherRole Category: OtherRole: OtherEmployement Type: Full time