47 Fda Regulations Jobs

Role & responsibilities Position Overview: We are seeking a highly skilled and experienced Senior Engineer in Quality Assurance to join our dynamic team at BiOZEEN. The successful candidate will play a key role in ensuring the highest standards of quality, compliance, and efficiency in our biopharmaceutical equipment qualification used for vaccine manufacturing processes. Job Description: 1) We are looking for an efficient, skilled, creative and experienced Senior Engineer - Quality Assurance to join BiOZEEN. 2) The successful candidate will work closely with the Dy. Manager Quality Assurance to ensure that our products meet quality and regulatory requirements. This includes overseeing and r...

Role Overview: Join Amgen's mission of serving patients living with serious illnesses by becoming a Principal IS Business Systems Analyst. At Amgen, you will play a vital role in advancing digital capabilities across Process Development Product Teams, driving agile delivery of digital solutions that enhance molecule selection processes. You will collaborate with business and technology leaders to provide strategic leadership and guidance in analyzing business requirements and designing information systems solutions. Your role will involve mentoring junior team members, leading technology strategy, and ensuring the seamless flow of instrument data across operational business processes. Key Re...

As a Senior Engineer at Linde, you will be responsible for the implementation of AOP Action, Fatality/FPE/LWC/TRC/FAC, and Pharmacovigilance Environmental incidents. Your role goes beyond the job description, impacting the people you work with, the communities you serve, and the world we live in. At Linde, the opportunities are limitless, allowing you to reach new heights and make a difference. Join us at Linde and embrace the limitless possibilities. In this position, you will ensure compliance with local regulations and obtain necessary approvals/licenses, particularly from the FDA. Your responsibilities will include selecting suitable suppliers, agreeing on technical solutions, conducting...

The Manufacturing QA Specialist in the Pharma Solutions division at Lexington plays a crucial role in ensuring compliance with regulations and standard operating procedures. You will be responsible for overseeing quality activities throughout the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products. Reporting to the QA Supervisor, you will review batch records, protocols, and documentation, collaborate with departments to address issues, and conduct on-the-floor activities like line clearances and product inspections. Your role will also involve providing QA oversight, troubleshooting GMP issues, and offering leadership on projects that interact with other de...

As a Senior Packaging Engineer, you will be responsible for designing, developing, and testing packaging solutions for medical devices. Your primary goal will be to ensure that the designs meet legal, quality, and cost requirements while protecting against environmental factors like moisture, chemicals, temperature, and tampering. Additionally, you will oversee the packaging design process from validation to manufacturing transfer, working collaboratively across different functions. Your key responsibilities will include designing both sterile and non-sterile medical device packaging in compliance with industry standards such as ASTM, ISTA, IEC, UL, FDA, and EU regulations. You will need to ...

The work you do every day at Illumina can have a profound impact on the lives of people globally. As part of a team dedicated to expanding access to genomic technology, you will contribute to the realization of health equity for billions of individuals. By enabling life-changing discoveries that improve human health through early disease detection, diagnosis, and innovative treatment options, you will play a crucial role in transforming healthcare for the better. Working at Illumina means being part of a larger mission that goes beyond individual contributions. Regardless of your role, you will have the opportunity to make a difference and grow professionally. Surrounded by exceptional colle...

J ob Title: Clinical Research Trainer Company: CLRI - CliniLaunch Research Institute Location: 3rd floor, Ozone Manay Tech Park, Kudlu Gate, Garebhavipalya, Garvebhavi Palya, Bengaluru, Karnataka 560068 Job Type: Full-Time Company Website- https://clinilaunchresearch.in/ We are seeking a highly skilled and experienced Clinical Research Trainer to join our dynamic team. The ideal candidate will possess a deep understanding of clinical research principles, data management best practices, and regulatory compliance requirements. You will be responsible for designing, developing, and delivering comprehensive training programs to our employees, covering a wide range of topics within these domains....

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. ...

As a member of the Finance department, you will be responsible for conducting comprehensive audits of IT hardware, software, network infrastructure, and cybersecurity measures. Your role will involve evaluating the effectiveness of IT controls and processes to ensure compliance with FDA regulations and other relevant standards. You will also need to identify and assess potential risks in IT systems and recommend mitigation strategies. In this position, you will be expected to prepare detailed audit reports that include findings, recommendations, and action plans. Collaboration with IT and other departments to implement audit recommendations and enhance overall IT governance will be a key asp...

As an AI Engineer at ManMukt, a pioneering organization dedicated to transforming mental healthcare through innovative AI solutions, you will play a crucial role in developing and implementing AI models specific to mental health applications. Your expertise will contribute to creating accessible, personalized, and effective digital health tools that aim to make quality mental healthcare available to everyone, everywhere. Your responsibilities will include designing, developing, and deploying sophisticated machine learning and deep learning models tailored for mental health, as well as leading the development of natural language processing systems to understand emotional and psychological con...

The Senior Regulatory Administrator (SRA) role is crucial in providing vital administration and operational support to the Regulatory Affairs department. As an SRA, your primary responsibility is to ensure the efficient management and upkeep of regulatory documents within the regulatory systems. Your pivotal role involves overseeing the accuracy, compliance, and timely submission of regulatory documentation to regulatory bodies such as the FDA, EMA, and other international authorities. Your duties will include managing the organization of regulatory documents for submissions, ensuring adherence to relevant guidelines and regulations, optimizing processes, mentoring team members, and fosterin...

As a Clinical Research Associate, your responsibilities will include developing and reviewing study protocols and informed consent documents, monitoring clinical trial progress to ensure adherence to GCP, FDA, and IRB regulations, collecting, managing, and analyzing clinical data, preparing regulatory submissions and study reports, and collaborating with cross-functional teams including investigators and coordinators. This is a full-time position suitable for freshers. The benefits include health insurance. The work schedule is during the day shift and the work location is in person.,

As a Labeling Specialist in the Pharmaceutical Industry, you will be responsible for developing US labeling documents to align with company goals and submission requirements for assigned ANDAs and/or 505(b)(2)s. Your role will involve ensuring that labeling meets all legal and regulatory requirements through QC, proofing, editing, and formatting of documents. You will coordinate the review and approval of final submission documents with all relevant departments. Your expertise will be crucial in developing labeling content that requires carve-outs due to protected language associated with patents/exclusivities. Serving as a Subject Matter Expert (SME) in SPL/drug listing, you will provide gu...

As an Implementation Consultant, you will be responsible for managing and assuming accountability for all aspects of projects related to implementation. Your key responsibilities will include guiding the client through release planning, managing communication throughout the team and stakeholders, leading product implementation efforts, coordinating with customers, product SME, and other teams, managing the quality of implementation deliverables, and documenting and reporting status on Risks, Issues, Actions, and Decisions. You will need to identify, report, and manage risks while overcoming project obstacles. Acting as a client liaison and representative, you will communicate client feedback...

This role as a Clinical Research HRPP Program Specialist involves serving as a lead for monitoring regulations and guidance to ensure the implementation of changes to operational processes or best practices for clinical research. You will provide expert advice to principal investigators (PIs), Clinical Research Coordinators, leadership, and other ORSP personnel involved in ensuring compliance throughout the lifecycle of clinical research and trials. Responsibilities include ongoing education and training of clinical research personnel, as well as on-site clinical research monitoring of industry-funded and investigator-initiated clinical research studies within the institution. Quality manage...

The Senior Quality Auditor provides support to the audit program and clinical projects to ensure compliance with regulations and Precision procedures. You will be responsible for offering oversight and subject matter expertise to quality and compliance activities, aiding project teams throughout all phases of a clinical study. Your essential job functions will include supporting the Quality Management System by managing SOPs, training, and CAPA. You will be required to process and maintain documentation for controlled documents as needed. Additionally, you will develop and conduct training for employees and consultants. Hosting client/sponsor audits, supporting regulatory inspections, coordi...

Are you seeking a rewarding career in Project Management within the Clinical Research industry Join Clario's Medical Imaging team in Bengaluru, India, and become a part of a legacy with over 30 years of expertise. Clario specializes in offering seamless, secure, and compliant medical imaging solutions that enhance clinical trials. At Clario, we have set ambitious goals and have a clear vision for the future. This is your opportunity to be a part of our journey as a Clinical Project Manager. What we offer: - Competitive compensation - Attractive benefits including security, flexibility, support, and well-being - Engaging employee programs - Technology for hybrid working and great onsite facil...

The Quality Control Specialist in our pharmaceutical company located in Thanjavur plays a crucial role in ensuring that all products adhere to quality standards and regulatory requirements before being released to the market. You will be responsible for conducting a variety of testing and analysis procedures on raw materials, in-process materials, and finished products. Your collaboration with the production team to identify and resolve quality issues will contribute to the continuous improvement of our quality systems and processes. Your key responsibilities will include performing routine and non-routine testing using various analytical techniques like HPLC, GC, and UV/VIS spectroscopy. Ad...

You are a passionate, dedicated, and detail-oriented professional, and an exciting opportunity awaits you to join the Quality Assurance Team at Zydus Takeda Healthcare Private Limited in Turbhe, Navi Mumbai. This joint venture between Zydus Lifesciences and Takeda Pharmaceuticals is committed to maintaining the highest level of quality and safety in its products. As a Senior Executive / Executive in Quality Assurance, based in Navi Mumbai, you will play a crucial role in In-Process Quality Assurance (IPQA). Your responsibilities will include monitoring and controlling the quality of products during the production process to ensure compliance with regulatory standards and company quality poli...

Job Description: Support daily DSCSA operations including product serialization, traceability, and exception handling. Coordinate with internal teams (QA, IT, Logistics) and external partners (CMOs, 3PLs, wholesalers) to ensure accurate product data exchange. Monitor and investigate DSCSA compliance issues such as "data no product" and "product no data" exceptions. Ensure accurate and timely submission of T3 data (Transaction Information, Transaction History, and Transaction Statement). Reconcile all outbound shipments from the 3PL using the middleware system to ensure compliance with DSCSA guidelines. Maintain records of DSCSA-related activities in compliance with FDA regulations. Assist wi...

You will be joining Vimson Derma, a renowned contract manufacturer of cosmetic and medicated products located in Ahmedabad with over 45 years of experience in the cosmetics and dermatology industry. As a trusted name in the field, Vimson Derma holds certifications such as GMP, GLP, and ISO 9001:2015, ensuring the highest quality standards. The company's product range includes dusting powders, talcum powders, shampoo, conditioner, cream, gel, lotions, oil, soaps, sunscreen, serums, and more. With a substantial client base of over 200 companies across India, Vimson Derma is committed to delivering excellence in the products they manufacture. As the R&D Senior Executive in Cosmetics, your prima...

Job Description: To apply to a Varex Imaging position, please create an account and sign-in. CURRENT VAREX IMAGING EMPLOYEES: Please apply by logging into your internal Workday Account. Varex Imaging is hiring a System Software Engineer in Test in the fast-growing X-Ray Imaging Components division. The Software Engineer in Test will bring real-world experience to our team by helping to develop automated integration and robustness testing to ensure system software performs as designed. We are looking for candidates that will thrive in a fast-paced, self-directed environment and can hit the ground running in a critical division of our company. There will be opportunities to work both individua...

The VP of Supply Chain at Piramal Critical Care (PCC) plays a pivotal role in overseeing and developing the Global Supply Chain operations under the strategic direction of the Executive Committee (Excom) and the EVP of Global Operations. In this position, you will be responsible for managing External Supply Operations, end-to-end Global Planning, Logistics, Procurement, revenue forecasting, and Supply Chain Operations across the three regions where PCC operates. As the VP of Supply Chain, you will collaborate with key stakeholders both internally and externally. Internal stakeholders include Regional Supply Chain heads, Excom Vice Presidents, Sales General Managers, and Alliance Management H...

As a Maintenance Engineer at our Pharmaceutical Company in Nagpur, Maharashtra, your primary responsibility will be to ensure the reliable operation, maintenance, and repair of mechanical systems and equipment in our manufacturing facility. In this role, you will play a crucial part in performing preventive and corrective maintenance, troubleshooting equipment issues, and ensuring compliance with regulatory standards to uphold production efficiency and safety. Your key responsibilities will include conducting routine preventive maintenance, inspections, and repairs on a variety of mechanical systems such as HVAC, pumps, compressors, and conveyors. You will also be expected to diagnose mechan...

The increasing demand for observational research (now commonly referred to as real-world evidence [RWE]) from regulatory and reimbursement authorities has made observational research a crucial component of drug development and commercialization. Amgen's Center for Observational Research (CfOR) is a global organization with industry-leading analytical capabilities that generate RWE to support business needs across a product's lifecycle. CfOR scientists collaborate with internal stakeholders and industry experts to design, conduct, interpret, and publish observational research that informs decision-making at various stages from molecule development to clinical trial design and the safety and e...