Senior Officer - Validation

PeopleStrong; Daman; On-site; INR 350,000 - 520,000; Full time

Job summary

PeopleStrong is seeking an Analytical Method Validation Specialist to execute AMV, MVerification, and AMT protocols for materials and products across dosage forms.

The role requires hands-on bench work to establish validation parameters (linearity, accuracy, precision, specificity, LOD/LOQ, robustness) and expert operation of HPLC, GC, UV‑Vis spectrophotometers, and dissolution equipment. Documentation and GDP adherence are essential.

Qualifications

• Analytical validation and data interpretation required.
• Postgraduate degree and MSc preferred for scientific rigor.
• MSc in analytical chemistry or related field is an advantage.

Responsibilities

• Execute approved AMV, Method Verification, and AMT protocols for raw materials, in-process samples, and finished products across dosage forms.
• Establish validation parameters including Linearity, Accuracy, Precision, Specificity, LOD/LOQ, and Robustness.
• Set up, operate, and maintain HPLC, GC, UV-Vis spectrophotometers, and Dissolution apparatus.
• Accurately prepare mobile phases, buffers, diluents, reference standards, and sample solutions for validation batches.
• Record all raw data, weights and observations in controlled worksheets and logbooks; follow ALCOA+ and GDP.

Skills

Analytical

Post Graduate

M.Sc.

Education

Post Graduate

M.Sc.

Job description

Sub Org Unit 3 Validation - Analytical Method

Country India

State Daman & Diu

Location Daman

Skills

• Analytical
• Post Graduate
• M.Sc.

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).