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 (India)
🏢 Alivus Life Sciences
📍 India