Satyavathi Komala

• Reviewing protocols and reports for the validation of analytical methods for solid oral dosage forms, parenterals, ophthalmic solutions, and oral solutions and suspensions.
• Assessing method development reports, including Certificates of Analysis and test reports.
• Evaluating validation documents related to dissolution profiles in various media (DPDM).
• Reviewing monograph evaluations and/or method verifications.
• Addressing regulatory inquiries regarding specifications, standard test procedures, and analytical method validations.
• Examining specifications and Standard Test Procedures (STPs) for bioequivalence studies, technology transfers, and regulatory submissions for solid orals, parenterals, ophthalmics, and oral solutions and suspensions.
• Reviewing risk assessment reports concerning residual solvents, elemental impurities, and nitrosamine's.
• Assessing analytical method validation documents for the Brazilian market in accordance with ANVISA RDC 166/53.
• Participating in Quality Management Activities, including reviewing incidents, change control forms, Out of Specifications (OOS), new initiation forms, and the locking and closure of forms.
• Involved in Quality Management Activities, including review of incidents, change control forms, new initiation forms, locking, and closure of forms.
• Involved in preparation and review of Quality Assurance departmental SOPs in eDMS.
• Also involved in review of Master Formula Record (MFR), Batch Manufacturing Record (BMR), Bill of Materials (BOM), Justification for Specifications (JOS).
• Effective management of resources assigned ensures that all available assets are used in the most productive way to achieve desired outcomes while maintaining efficiency and adapting to changing needs or conditions.

• Performed routine analysis of in-process and finished products (tablets and capsules) according to ICH guidelines and in-house specifications using the Laboratory Information Management System (Labware-LIMS).
• Conducted various tests including solubility, conductivity, and pH for active pharmaceutical ingredients (APIs).
• Proficient in High-Performance Liquid Chromatography (HPLC) for various analyses.
• Provided regular online support to production with HPLC analyses, such as assay, dosage uniformity, dissolution, and related substances.
• Conducted chemical water analysis including tests for conductivity, Total Dissolved Solids (TDS), hardness, Total Organic Carbon (TOC), heavy metals, nitrates, and pH for raw, potable, and purified water.
• Assisted in the calibration of HPLC, KF Auto Titrator, disintegration tester, and pH meter.
• Reviewed chromatographic data and analytical results in compliance with regulatory requirements to generate quality documentation.
• Performed physical tests, such as disintegration time, water content determination by KF Auto Titrator, and hardness testing.
• Adhered to Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), safety regulations, and laboratory Standard Operating Procedures (SOPs) as per company policies.
• Coordinated with production departments to manage priorities and address urgent matters.
• Responsible for the qualification, evaluation, and maintenance of working standards.
• Involved in verifying logbooks and related documentation.
• Involved in the issuance of working standards on a daily basis.
• Responsible for compilation of stability summary data.

Responsible for review of Empower Analytical data (Assay, dissolution and related substance).

Review of in-process related documents, including blend assay and blend uniformity.

Handling and calibration of instruments like HPLC.

Guide and train junior team members.

• Involved in wet analysis including Solubility, pH, Conductivity, Loss on Drying (LOD), Sulphated Ash.
• Involved in UV analysis, FTIR Spectroscopy, Specific Optical Rotation (SOR), Potentiometry.
• Calibration of pH meter, conductivity meter, analytical balance, KF standardization, and determination of halogens by non-tertiary amines.