6 Usfda Guidelines Jobs

As a Safety Specialist II at our company, your role will involve the following responsibilities: - Authoring and reviewing various Aggregate Safety Reports such as DSURs, PBRERs, PSURs, PADERs, and Canadian Aggregate Reports as required by the project. - Reviewing aggregate safety data, generating line listings (LL) and summary tabulations (ST), and incorporating them into the appropriate templates. - Analyzing safety and regulatory data provided by clients to prepare comprehensive Aggregate Reports. - Conducting literature screening to include significant safety articles in the respective sections of aggregate reports. - Compiling benefit-risk evaluation sections provided by medical reviewe...

Role Overview: You should have a good knowledge of ANDA submission activities and post-approval procedures along with related ICH and USFDA guidelines. Your responsibilities will include API DMF review in accordance with USFDA regulatory requirements, exposure to various dosage forms, preliminary review of change cases, drafting annual reports, reviewing submission packages, drafting controlled correspondence, and ensuring regulatory submissions are completed without delay. Coordination with cross-functional teams and maintaining regulatory information will also be part of your role. Key Responsibilities: - Review API DMF with respect to USFDA regulatory requirements - Understand and brief m...

As a Bioanalytical Scientist at our company, you will be responsible for: - Developing and validating bioanalytical methods using LCMS and other sophisticated instruments - Carrying out routine calibration of instruments - Demonstrating a thorough knowledge of LCMS, HPLC, HPTLC, GCMS, and other analytical instruments - Ensuring compliance with USFDA guidelines - Utilizing excellent communication skills to effectively coordinate with team members - Displaying good interpersonal and management skills - Holding strong basic knowledge of analytical instruments such as HPLC and LC-MS - Being accountable for group productivity, including the number of samples, analysis quality, quantity, and timel...

Job Purpose: To operate and monitor granulation equipment and processes in compliance with cGMP, SOPs, and safety standards, ensuring consistent production of high-quality pharmaceutical granules for tablet or capsule formulation. Key Responsibilities Operate granulation equipment such as high-shear mixers, fluid bed dryers, oscillating mills, and blenders. Weigh, dispense, and mix raw materials as per batch manufacturing records (BMR). Monitor granulation parameters and adjust settings to maintain product quality. Perform in-process checks (e.g., moisture content, granule size) and document results accurately. Clean and maintain equipment and work areas as per SOPs. Execute machine changeov...

As a Senior/Lead Medical Reviewer with 1 3+ years of experience in Aggregate Reporting, Signal Management, or RMP, you will play a crucial role in our team. Your responsibilities will include overseeing the implementation of operational tasks in safety writing, monitoring service performance, and mentoring employees to ensure independent work within timelines, budget, and quality standards. Your duties will involve reviewing RMP/PSUR or any aggregate documents for medical cohesiveness, managing the logistical aspects of safety reports" development, and collaborating with authors from different line functions to meet client and Health Authorities" requirements. You will also be responsible fo...

As a Process Head at Kavs Spectronova Technologies Pvt Ltd, you will be responsible for leading the process engineering aspects of pharmaceutical plant projects. Your role will involve overseeing optimal process design, ensuring regulatory compliance, and facilitating seamless coordination among internal and external stakeholders for both greenfield and brownfield facility projects within the pharmaceutical industry. Your key responsibilities will include leading the end-to-end process design for various types of pharmaceutical facilities such as OSD, Injectable, Vaccine, or Biotech. You will be required to develop and review essential documents including P&ID, Process Flow Diagrams, Mass Ba...