Ranjan Samanta Email & Phone Number

Navi Mumbai, Maharashtra, India

• Conducting method development and validation of API/ Formulations. • Prepare the different type of protocol of stability study and method validation protocol.• Review stability study data of DS/ drug product and prepare the outcome collected data in report form. • Quality response providing to customer and HA queries.

Hyderabad, Telangana, India

• Rich experience in analytical technique/method development strategies, stability studies, validation protocols & summary reports, technology transfer and compliance.• Leading/assisting a group of 5-7 scientists, aligning with project team leads, planning analytical activities and resolving issues.• Collaborates closely with project team leads to ensure alignment on analytical deliverables and oversees the tracking of action plans, ensuring timely completion of tasks for assigned projects.• Strategically plans analytical activities, demonstrating a proactive approach in resolving issues and errors encountered during analysis, contributing to the overall efficiency of the project.• Possesses hands-on experience in conducting protocol-based studies, leading investigations into Out-of-Specification (OOS) and Out-of-Trend (OOT) results, and effectively implementing Change Control & Corrective and Preventive Action (CAPA) measures. Demonstrates expertise in ensuring pharmacopoeia method equivalency.• Takes ownership of preparing GMP relevant documents within the assigned area of responsibility, showcasing a keen eye for recognizing and addressing complex deficiencies in GMP documents.• Plays a pivotal role in the planning of daily, weekly, and monthly activities, optimizing available resources based on project requirements. Ensures the implementation of Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and safety protocols in the laboratory.• Evaluates Drug Substance specifications and methods of analysis, guaranteeing the generation of necessary data to qualify compliance with regulatory standards.• Assumes responsibility for conducting internal audits and self-inspections, contributing to the continuous improvement of processes and adherence to quality standards.• Generates Laboratory Information Management System (LIMS) Protocols, Specifications, and technical documents, enhancing data management and documentation practices.