Senior Officer Validation
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Monthly Salary:
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Job Summary
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).
Required Experience:
Senior IC
