Senior Manager
Azurity Pharmaceuticals India LLP
01.2025 - Current
- Review the Drug Master File (DMF) provided by Active Pharmaceutical Ingredient (vendor) and address the deficiencies.
- Literature search for the analytical method development of the pharmaceutical’s dosage form related to assay, Impurity profiling and force degradation studies.
- Performing the Assay, Content Uniformity & Related Substances of the Dosage forms.
- Involved in the method development activities i.e., like Assay, Dissolution and Related Substances.
- Performing the Particle Size Distribution of the Pharmaceutical Dosage forms and Drug Substances.
- Calibration of lab instruments and maintenance of records as per schedule.
- Preparation of Analytical test methods and Method development reports of the pharmaceutical dosage forms.
- Preparation of Technical summary reports for the regulatory agencies.
- Preparation of Specification for the Pharmaceutical dosage forms.
- Preparation of Certificate of Analysis of BE NOC, Pilot bio studies and method validation.
- Preparation of Standard Operating procedure (SOP) pertaining to the Analytical development.
- Maintaining of Analytical standards and impurities related to the projects.
- Attending the product analytical technical review meetings with CMO and CTL.
- Review the Certificate of Analysis and characterization reports of Impurities received from the vendor and other sources.
- Review of the Method verification, method development, reports.
- Review of the method feasibility, Analytical method validation protocols and Analytical method validation reports from CMO and CTL.
- Handling and responding the queries/ deficiencies received from regulatory agencies.
- Handling and resolve any technical issues of analytical activities at CMO & CTL.
- Follow the Quality Management system (QMS) present in the organization for running the analytical activities such as change control and laboratory incidents.
- Monitoring the analytical lab compliance.