Research Associate/Officer in Analytical Dept _Alivus Life Sciences

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 Good 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.