Senior Executive - AMV
Job Description
Protocol & Report Writing: Draft, review, and execute Analytical Method Validation, Method Verification, and Method Transfer protocols and final reports for various dosage forms in accordance with current ICH, USP, and FDA guidelines.
Method Execution: Independently perform validation parameters including Specificity, Linearity, Accuracy, Precision (Repeatability & Intermediate Precision), Limit of Detection (LOD), Limit of Quantitation (LOQ), and Robustness.
Method Transfer (AMT): Coordinate and execute the seamless transfer of analytical methods from Analytical R&D (AR&D) to the Quality Control laboratory, or from site to site, ensuring all acceptance criteria are met.
Instrument Expertise: Operate, calibrate, and troubleshoot advanced analytical instrumentation, primarily HPLC, GC, UV-Vis, Dissolution testers, and KF Titrators.
Troubleshooting: Act as the technical Subject Matter Expert (SME) to troubleshoot analytical methods during the validation or transfer phase. Optimize methods to resolve baseline disturbances, resolution issues, or standard failures.
Investigations: Lead laboratory investigations for any Out of Specification (OOS), Out of Trend (OOT), or protocol deviations encountered during validation activities, performing rigorous root-cause analysis