7 Fda Standards Jobs

Role Overview: As a Service Manager for medical devices in Noida, you will be responsible for overseeing the service operations, including installation, maintenance, and after-sales support. Your role will involve team leadership, customer relationship management, and ensuring compliance with healthcare standards and regulatory requirements. Key Responsibilities: - Lead, supervise, and mentor the service & application team across regions. - Plan, coordinate, and monitor preventive maintenance, breakdown calls, and product installations. - Develop and implement service policies, SOPs, and escalation procedures. - Ensure compliance with medical device regulatory requirements and hospital proto...

As a passionate and goal-oriented Engineer, you will be dedicated to delivering safe and robust solutions while keeping the customer and requirements at the forefront. You will excel in analytical problem-solving, identifying root causes, evaluating optimal solutions, and recommending comprehensive upgrades to prevent future issues. In a fast-paced environment, you will stop at nothing to ensure project completion while meeting regulations and expectations. Your self-driven and curious nature will lead you to take initiative, hold yourself accountable, and seek cutting-edge research to enhance your ability to develop new ideas into reality. Effective communication will be key as you interpre...

Role Overview: As a Chemical Testing Analyst at the company, your primary responsibility will be reviewing and conducting chemical testing of various products, including raw materials, finished products, cosmetics, Ayurveda, Sidha & Unani products. You will play a crucial role in ensuring the accuracy of test results entered into the LIMS software. Furthermore, you will be tasked with handling advanced instruments such as HPLC, GC, FTIR, Dissolution, etc. Another significant aspect of your role will involve preparing technical documentation that adheres to FDA, CDSCO, and Ayush standards for audits. Key Responsibilities: - Review and conduct chemical testing of raw materials, finished produc...

As a Sr. Validation Engineer at CMIC CMO USA Corporation in Cranbury, NJ, your role involves utilizing pharmaceutical science analytics to author validation protocols in compliance with cGMP/FDA standards. You will be responsible for planning, managing, and executing start-up, commissioning, and validation of new pharmaceutical equipment. Additionally, you will draft and implement qualification protocols, resolve deviations and CAPA, prepare validation reports, develop SOPs for manufacturing and packaging equipment, as well as write test protocols. **Key Responsibilities:** - Author validation protocols in compliance with cGMP/FDA standards - Plan, manage, and execute start-up, commissioning...

Tris Pharma, Inc. is a leading biopharmaceutical company with a focus on developing and commercializing innovative medicines to address unmet patient needs in areas such as ADHD, spectrum disorders, anxiety, pain, and addiction. With over 150 US and International patents, we market branded ADHD products in the U.S. and license our products globally. Our robust pipeline of innovative products spans neuroscience and other therapeutic categories, driven by our unique science and technology. At Tris Pharma, our team members are the heart of our success. We value a culture of passion, innovation, and collaboration. We believe in respectful, open, and honest communication to support individual and...

As a Project Lead at OneOrg.ai, you have the exciting opportunity to expand the AI Superbrain into the realm of pharma manufacturing. In this role, you will play a crucial part in transforming digitization from a future plan to a regulatory and business imperative. Your main responsibility will be to identify high-impact AI use cases within manufacturing, such as visual deviation detection, batch yield variance, and SOP non-compliance, and lead short-cycle projects to deliver visible value to clients. Ideally, you should have 8-15 years of experience in pharma manufacturing, QA/QC, or GMP automation, with deep exposure to GMP documentation, audit trails, batch monitoring, and deviations. Pri...

As an Embedded Application Software Engineer at our company, you will be part of a dynamic team that values passion, goal-orientation, analytical problem-solving, dedication, self-driven learning, and effective communication. Your role will involve the development, enhancement, and testing of embedded software applications and middleware. You will independently focus on embedded software development and testing while also providing support to your colleagues. Your responsibilities will include active participation in various stages of software development using defined SDLC and development models for projects. Minimum Qualifications: - 8+ years of work experience in Embedded Software Applica...