Senior Officer - Validation
Job Description
Protocol Execution: Execute approved AMV, Method Verification, and AMT protocols for raw materials, in-process samples, and finished products across various dosage forms.
Validation Parameters: Perform hands-on bench work to establish critical validation parameters, including Linearity, Accuracy, Precision (System, Method, and Intermediate), Specificity, Limit of Detection (LOD), Limit of Quantitation (LOQ), and Robustness.
Instrument Operation: Set up, operate, and maintain key analytical instrumentation, primarily HPLC, GC, UV-Vis Spectrophotometers, and Dissolution apparatus.
Sample & Standard Preparation: Accurately prepare mobile phases, buffers, diluents, reference standards, and sample solutions required for validation batches.
Documentation & Data Integrity: Record all raw data, weights, and observations contemporaneously in controlled worksheets and logbooks. Ensure strict adherence to ALCOA+ principles and Good Documentation Practices (GDP).