Junior Scientist/ Scientist - Analytical Research & Development

Sarvotham Care; Hyderabad; On-site; INR 600,000 - 900,000; Full time

Job summary

Sarvotham Care in Hyderabad, India invites a skilled analytical chemist to drive method validation of assay and dissolution per ICH guidelines and to analyze finished products as per STP. You will also qualify and maintain working standards and coordinate sample submission to external laboratories, managing reports and records.

Responsibilities include dissolution media studies with result compilation, regular stability analysis, operation and maintenance of stability chambers, and strict

Qualifications

• Analytical method validation expertise and knowledge of ICH guidelines.
• Experience with analysis of finished products per STP.
• Qualification and maintenance of working standards.
• Coordination with external laboratories for sample submission and report management.
• Dissolution testing and media studies with result compilation.
• Regular stability analysis and operation of stability chambers.
• Documentation: GLP, GDP, CGMP compliance and records maintenance.
• COA generation for working standards and finished products.
• Protocol-based studies involvement.

Responsibilities

• Handle analytical method validation of assays and dissolution per ICH.
• Analyze finished products as per STP.
• Qualify and maintain working standards.
• Coordinate sample submissions to external labs and manage reports.
• Dissolution media studies and result compilation.
• Regular stability analysis and stability chamber maintenance.
• Maintain GLP/GDP/CGMP documentation and records.
• Generate COAs for standards and finished products.
• Carry out protocol-based studies.

Job description

Role & responsibilities

• Handling of Analytical Method validation of Assay and dissolution as per ICH Guidelines.
• Responsible for the Analysis of Finished products as per STP.
• Responsible for the Qualification and Maintenance of Working Standards.
• Responsible for sending of samples to external laboratory and receiving of reports. Maintenance of records / documents for external laboratory services.
• Dissolution: Carrying out different Media study with compilation of results.
• Regular Stability Analysis: Well versed with handling of regular Stability samples analysis.
• Operation and regular maintenance of stability chambers.
• Documentation: Good knowledge on GLP, GDP, CGMP and maintenance of records, usage logbooks.
• Responsible for report preparation after completion of the analysis.
• Responsible for generating COAs for working standards and finished products.
• Responsible for Protocol based studies.

OPERATION AND CALIBRATION OF THE FOLLOWING INSTRUMENTS:

• Knowledge on HPLC with Empower 2 and 3 Software. (UV/PDA)
• Knowledge on UV-Visible Spectrometer.
• Knowledge on Dissolution Tester.
• Knowledge on Operation and Maintenance

NOTE:

Immediate joiners pereferable