Senior Executive - AMV

PeopleStrong; Daman; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

PeopleStrong in India seeks a skilled Analytical Method Validation Specialist to lead validation activities for multiple dosage forms in line with ICH, USP, and FDA guidelines. You will perform validation parameters (specificity, linearity, accuracy, precision, LOD/LOQ, robustness), coordinate method transfers, and operate instruments such as HPLC, GC, UV-Vis, dissolution testers, and KF titrators.

The role includes troubleshooting, investigations of OOS/OOT events, and driving root-cause

Qualifications

• 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.
• Independently perform validation parameters including Specificity, Linearity, Accuracy, Precision (Repeatability & Intermediate Precision), LOD, LOQ, and Robustness.
• Coordinate and execute the seamless transfer of analytical methods from AR&D to QC laboratory, or from site to site, ensuring all acceptance criteria are met.
• Operate, calibrate, and troubleshoot advanced analytical instrumentation, primarily HPLC, GC, UV-Vis, Dissolution testers, and KF Titrators.
• Act as SME to troubleshoot analytical methods during the validation or transfer phase. Optimize methods to resolve baseline disturbances, resolution issues, or standard failures.
• Lead laboratory investigations for any OOS, OOT, or protocol deviations encountered during validation activities, performing rigorous root‑cause analysis.

Responsibilities

• Draft, review, and execute validation protocols and final reports for analytical methods.
• Coordinate and execute method transfers between AR&D and QC laboratories or across sites.
• Troubleshoot and optimize analytical methods during validation or transfer to meet acceptance criteria.

Skills

Analytical Method Validation

HPLC

Method Transfer

OOS/OOT Investigations

Validation Reports

Tools

HPLC

GC

UV-Vis

Dissolution testers

KF Titrator

Job description

Sub Org Unit 3 Validation - Analytical Method

Country India

State Daman & Diu

Location Daman

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.