Senior Executive AMV

• 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

Required Experience:

Senior Exec