Sunita Choudhary

1. Preparation of Analytical Method Validation Protocols and Reports:

Protocols: Develop comprehensive validation protocols detailing objectives, scope, and requirements for assay methods, and related substance tests. Define parameters such as accuracy, precision, specificity, and robustness.
Reports: Document validation outcomes, compare results against acceptance criteria, and identify any deviations. Provide data-driven conclusions, and recommend corrective actions where necessary.

2. Analytical Method Validation for Assays and Related Substances:

Design and execute method validation studies for assays and related substance testing (e.g., HPLC, IC) for both drug substances and drug products. Ensure methods are validated for parameters such as accuracy, precision, specificity, and robustness.

3. Development of Operational and Calibration SOPs:

• Operational SOPs: Create detailed standard operating procedures (SOPs) for laboratory processes, ensuring consistency and compliance with regulatory standards (e.g., cGMP).
• Calibration SOPs: Establish SOPs for the regular calibration of analytical instruments, ensuring compliance with the appropriate standards, and ensuring accurate, reproducible results.

4. Change Control and Justification Documentation: Prepare justifications for proposed changes to analytical methods, instrumentation, or procedures. Follow the change control process to ensure all changes are evaluated, documented, and approved before implementation.

5. Preparation of Standard Analytical Procedures: Develop and document standardized procedures for routine analyses. Ensure these procedures adhere to regulatory standards (e.g., ICH, USP), and support consistent results in laboratory operations.

6. Incident Investigations, OOS, and Deviations Management: Lead investigations of out-of-specification (OOS) results and deviations from established procedures. Determine root causes, assess impacts, and develop corrective actions. Maintain thorough documentation of investigations, findings, and resolutions in line with cGMP requirements.

7. Routine Analysis of R&D Samples: Conduct routine analyses on R&D samples, ensuring data integrity, and alignment with project requirements. Ensure timely reporting and documentation of results.

8. Instrument Calibration (HPLC, IC, etc.)
Oversee the calibration of analytical instruments, including HPLC and IC, in accordance with SOPs. Ensure compliance with calibration schedules, and troubleshoot issues to maintain accurate and reliable performance.

9. Cross-Departmental Coordination: Collaborate with key departments such as Regulatory Affairs, Plant Quality Control, Formulation, and R&D QA to ensure the smooth execution of projects. Ensure validation protocols, reports, and analytical methods align with regulatory requirements and project timelines.

10. Assay and Related Substances Method Development: Develop and optimize assay methods and related substance testing for drug substances and drug products using HPLC, ensuring both robustness and regulatory compliance.

• Instrument Calibration: Expertise in calibrating HPLC (Waters, Thermo Scientific), IC (Thermo Scientific), UV/IR (Shimadzu), Karl Fischer, and Auto titrators (Metrohm).
• Routine Analysis: Proficient in conducting assays, related substances, and content analysis of drug substances.
• Method Development: Skilled in developing analytical methods for drug substances and solid oral dosages using HPLC and IC.
• Analytical Method Validation: Experienced in preparing and executing analytical method validation protocols and reports in accordance with ICH guidelines.
• QMS Documentation: Strong experience in managing incident, deviation, change control, and OOS documentation.
• Software Proficiency: Advanced knowledge of DocuSign, Chromeleon, Empower, Tiamo, and LabSolutions for data analysis and documentation.