Role & responsibilities

Analytical Method Development

- Develop analytical methods using HPLC, UPLC, GC, UV, FTIR, KF, Dissolution, and other analytical techniques.

- Conduct method optimization and troubleshooting for API and intermediate analysis.

- Perform forced degradation and stability-indicating method development studies.

- Establish impurity profiling and characterization strategies.

Method Validation & Transfer

- Execute analytical method validation as per ICH Q2 guidelines.

- Prepare validation protocols and reports.

- Support analytical method transfer to QC, manufacturing sites

Laboratory Operations

- Operate, maintain, and troubleshoot analytical instruments.

- Ensure laboratory compliance with data integrity and GMP requirements.

- Maintain analytical records, logbooks, and documentation.

Regulatory Support





- Generate analytical data for DMF, ANDA, CEP, and other regulatory submissions.

- Support responses to regulatory queries and audits.

- Review specifications, analytical procedures, and stability data.

Documentation

- Prepare SOPs, analytical reports, specifications, STPs, and development reports.

Ensure documentation complies with Positive Documentation Practices (GDP).

Preferred candidate profile

Preferred Competencies

- Problem-solving and investigation skills.

- Regulatory compliance orientation.

- Cross-functional collaboration with R&D;, QA, and Manufacturing teams.

- Effective communication and report-writing skills.

📌 Research Associate/Officer in Analytical Dept _Alivus Life Sciences (Navi Mumbai)
🏢 Alivus Life Sciences
📍 Navi Mumbai