Job Description

· Execute Analytical Method Development activities of drug products based on QbD principles and regulatory requirements. · Execution of Analytical Method validation activities for drug products as per the regulatory requirements. · Execute routine Analytical Research activities of drug products. · Establishing In-house systems and procedures to ensure cGLP practices & regulatory requirements for analytical activities at In-house R&D facility. · troubleshooting related to Testing methods, Stability studies, test results, and designing of additional experimentations as necessary · Execution & coordination for Analytical method transfer activities of drug products. · Calibration of the Analytical instruments as per the master calibration schedule. · Technical assessment & Analysis of drug substances (API) for projects execution. · Review & clearance of technical documents leading to dossier batches executions and registrations. · Preparation and review of Specifications, Method of analysis procedures, and Analytical development reports. · Preparation and review of analytical protocols and reports (Analytical method validation, Method feasibility, Analytical method transfer, etc.). · Technical assessments of projects (Screening, pipeline, and development projects stages) & Literature search). · Preparation of analytical technical documents for dossier / Technology transfer executions / Regulatory submissions of projects. · Assisting and resolving technical quires raised during Technology transfer activities & regulatory submissions. · Assisting in the establishment of In-house Infrastructure (Analytical equipment’s Qualifications and preparation of SOP’s). · Assessment & coordination on regulatory deficiencies. · Assisting with analytical requirements in finalization of project costings..

Requirements:

· Bachelor Degree in Pharmacy · Experience: 5-10 years as a methodologist in (solid, semisolid, liquid and potent drugs) · Minimum 2 years of experience in developing potent drugs (hormones and oncology drugs)