Analyst - Research & Development

JobItUs; Bharuch District; On-site; INR 600,000 - 800,000; Full time

Job summary

JobItUs in Gujarat invites an Analytical Scientist to develop, optimize, and troubleshoot analytical methods for assay, dissolution, and related substances. You will execute method validation per ICH guidelines, ensuring accuracy, precision, specificity, linearity, and robustness.

You will operate HPLC, GC, UV-Vis, FTIR, and Karl Fischer titrators, support stability studies and shelf-life determinations, and maintain complete raw data, protocols, and reports in compliance with GLP, cGMP, and

Qualifications

• Experience in analytical method development for assay, dissolution, and related substances.
• Ability to validate methods per ICH guidelines including accuracy, precision, specificity, and robustness.
• Hands-on operation and troubleshooting of HPLC, GC, UV-Vis, FTIR, and Karl Fischer titrators.
• Conduct stability studies and support shelf-life determinations.
• Maintain GLP/cGMP compliant documentation and data integrity.
• Coordinate with QC, QA, R&D, Production, and Regulatory Affairs.

Responsibilities

• Develop, optimize, and troubleshoot analytical methods for assay, dissolution, related substances, and impurities.
• Execute analytical method validation as per ICH guidelines including accuracy, precision, linearity, range, robustness, and system suitability.
• Operate and troubleshoot instruments; interpret analytical data from HPLC, GC, UV-Vis, FTIR, and Karl Fischer titrators.
• Perform stability studies and evaluate results to support shelf-life and storage recommendations.
• Maintain complete raw data, protocols, reports, and validation documentation per GLP and cGMP.
• Collaborate with QC, QA, R&D, Production, and Regulatory Affairs to support formulation development and regulatory submissions.

Skills

Analytical Method Development

Method Validation

Cross-functional Collaboration

Documentation & Data Integrity

Tools

HPLC

GC

UV-Vis

FTIR

Karl Fischer titration

Job description

• Analytical Method Development: Develop, optimize, and troubleshoot analytical methods for assay, dissolution, related substances/impurities, and residual solvents.
• Method Validation: Execute analytical method validation as per ICH guidelines, including accuracy, precision, specificity, linearity, range, robustness, and system suitability.
• Instrument Operation: Hands-on experience with HPLC, GC, UV-Vis, FTIR, and Karl Fischer titrators, including instrument troubleshooting and data interpretation.
• Stability Studies: Perform analysis of stability samples and evaluate analytical results to support shelf-life determination and recommended storage conditions.
• Documentation & Compliance: Maintain complete raw data, analytical records, protocols, reports, and validation documentation in compliance with GLP, cGMP, and data-integrity requirements.
• Cross-Functional Collaboration: Coordinate with QC, QA, R&D, Production, and Regulatory Affairs teams to support formulation development, technology transfer, investigations, and regulatory submissions.