88 Fda Regulations Jobs - Page 2

Job Description: Technician Compression Job Purpose To operate and maintain tablet compression equipment in compliance with cGMP, SOPs, and safety standards, ensuring consistent production of high-quality tablets. Key Responsibilities Set up and operate tablet compression machines and ancillary equipment (e.g., metal detectors, dedusters, friability testers, scales). Perform in-process checks such as tablet weight, thickness, hardness, and visual inspection as per Master Batch Records (MBR). Clean and sanitize equipment and manufacturing areas according to SOPs. Accurately complete equipment logs and batch documentation. Ensure proper execution of MBRs, SOPs, and validation protocols. Coordi...

As a Regulatory Administrator at our company, you will play a vital role in providing administrative and operational support to the Regulatory Affairs department to ensure the smooth facilitation of the regulatory submissions process. Your responsibilities will include: - Uploading, organizing, and maintaining regulatory documents within various regulatory authority submissions portals such as CTIS, FDA eGateway, and CESP. - Coordinating the redaction of confidential information in regulatory documents and ensuring compliance with global standards. - Collaborating with external vendors for document redaction services and monitoring the progress of redaction processes. - Assisting in preparin...

Role Overview: As the Head of Engineering & Maintenance at a large-scale API pharmaceutical plant in Digwal, Hyderabad, you will be leading all engineering and maintenance operations. Your primary responsibility will be to ensure the optimal performance, reliability, and compliance of plant equipment, systems, and facilities. Your extensive experience in API manufacturing, expertise in CGMP, FDA regulations, and managing regulatory audits will be crucial in developing and executing maintenance strategies, driving continuous improvement, managing OPEX budgets, and leading a high-performing team to ensure safe, efficient, and compliant plant operations. Key Responsibilities: - Lead, manage, an...

As a Solution Architect for In-Market Logistics Operations at Bristol Myers Squibb, you will be responsible for supporting the design and implementation of digital and process solutions to ensure seamless delivery of products on a global scale. Your role will involve overseeing the development and operation of In-Market Distribution Centers, regional logistics hubs, inventory ownership models, and 3rd Party Distributor Order Management. To excel in this role, you will need a strong understanding of logistics and warehousing operations, technical expertise, and the ability to collaborate with cross-functional teams to deliver innovative solutions that meet business needs. Key Responsibilities...

As a Scientist at USP, your role will involve conducting necessary analytical tests on Verification samples (Dietary supplements/Dietary Ingredients) utilizing suitable methods to enhance the laboratory's scientific proficiency and work ethic. You will offer extensive technical support and knowledge and provide valuable observations and insights into challenging projects. Your responsibilities will include: - Conducting verification projects (Dietary Supplements/Dietary Ingredients) by performing individual analytical tests such as HPLC, GC, Dissolution, ICP-MS, ICP-OES, and wet analysis as assigned - Completing projects within designated timelines and priorities - Demonstrating a robust sci...

Medical Writer II (CSR Narrative exp Only) at Syneos Health Syneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. Our focus is on translating unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities. In our Clinical Development model, the customer and the patient are at the core of everything we do. We are constantly seeking ways to simplify and streamline our work to not only enhance the ease of collaboration with Syneos Health but also to make working for us more straightforward. Whether you are part of a Functional Service Provider partnership or a Full-Service en...

As a Clinical Trial Site Manager, your main responsibility will be to monitor and manage clinical trial sites to ensure the smooth and compliant conduct of trials. Your key responsibilities will include: - Ensuring compliance with protocols and regulations such as GCP and FDA - Verifying the accuracy of patient data and clinical records - Training site staff on trial procedures - Preparing reports and providing assistance during audits or inspections In addition to the responsibilities outlined above, you will be required to work full-time in a day shift schedule at the in-person work location. The company provides health insurance as part of the benefits package.,

As an experienced Regulatory Affairs Consultant with specialized knowledge in lipid-based pharmaceutical products, particularly Fish Oil Triglycerides such as EPA/DHA omega-3 fatty acids, your role will involve providing regulatory support and strategic guidance for drug, dietary supplement, or nutraceutical products containing fish oil derivatives to ensure compliance with global regulatory standards including FDA (CDER & CFSAN). You will be a crucial resource within the organization, offering technical expertise and regulatory guidance for the development, manufacturing, and commercialization of lipid-based pharmaceutical products. Your role will require strong cross-functional collaborati...

As the Head of Engineering & Maintenance at Piramal Pharma Solutions, you will play a crucial role in leading all engineering and maintenance operations for a large-scale API pharmaceutical plant located in Digwal. Your responsibilities will include ensuring optimal performance, reliability, and compliance of plant equipment, systems, and facilities. Your extensive experience in API manufacturing, expertise in CGMP, FDA regulations, and managing regulatory audits will be essential in this role. **Key Responsibilities:** - Lead, manage, and develop the Engineering & Maintenance team to drive plant operational excellence. - Develop and execute a comprehensive maintenance strategy, ensuring a p...

Role Overview: You will be responsible for conducting necessary analytical tests on Verification samples (Dietary supplements/Dietary Ingredients) using suitable methods in a non-supervisory role. As a Scientist at USP, you will enhance the laboratory's scientific proficiency and work ethic by providing extensive technical support and knowledge. Proficient in various common laboratory techniques, you will offer valuable observations and insights into challenging projects, aiding the Verification Program by executing analytical tests and preparing comprehensive summary reports. Key Responsibilities: - Conduct verification projects on Dietary Supplements/Dietary Ingredients by performing indiv...

Role Overview: You will be responsible for overseeing the Research & Development (R&D) activities related to Frozen Foods, Ready to Eat, Snacks, and Baking products. Your expertise in the field, combined with your academic background, will play a crucial role in ensuring the success of our R&D projects. Key Responsibilities: - Lead and manage R&D projects in the areas of Frozen Foods, Ready to Eat, Snacks, and Baking - Utilize your technical know-how to drive innovation and product development - Ensure compliance with FDA, EU, and FSSAI regulations throughout the R&D process - Collaborate with cross-functional teams to optimize production processes and quality standards - Stay updated on ind...

Role Overview: As a Clinical Data Manager at Clinvigilant Research Pvt. Ltd., a company of GSC Group, located onsite in Ahmedabad, you will play a crucial role in managing and overseeing the data collected during clinical trials. With 3 to 6 years of experience in clinical data management or a related field, you will ensure the accuracy, integrity, and compliance of clinical trial data with regulations. Key Responsibilities: - Oversee the collection, management, and quality control of clinical trial data. - Develop, implement, and maintain the Data Management Plan (DMP) for clinical trials. - Design and build electronic data capture (EDC) systems and clinical databases in collaboration with ...

Role Overview: You will be responsible for utilizing your expertise in Medical Electronics Design & Consulting to contribute to the introduction of Medical Technology. With over 10 years of experience in the field, you will play a crucial role in the complete Medical electronic devices/equipment/product Design Lifecycle, covering aspects such as Value Discovery, architecting, Design, and Testing. Your exposure will extend to current architectures like Internet of Medical Things (IoMT), Microservices/SoA, AI enabled therapeutics/diagnostics/medical imaging/personalized medicine/prognostics/telemedicine, SaMD, Digital healthcare/surgical platforms, etc. Furthermore, your knowledge of Robotics ...

The role of Analyst, Global Complaint Management (Customer Response) within the Quality team as an Associate based in Chennai, India involves managing device or pharmaceutical complaints and adverse events on a global scale. Your responsibilities include: - Initial triage of complaint files - Assessing reportability - Escalating customer advocacy events - Submitting regulatory reports as per applicable regulations - Referring potential safety cases - Obtaining additional information for events - Providing updates to reports - Ensuring timely processing of complaint files for regulatory reporting purposes In this role, you will be required to: - Draft and send professional and clear responses...

Oversees multiple regulatory specialists at clinical research sites, ensuring timely regulatory submissions, IRB documentation, compliance with evolving regulations, training oversight, audit coordination, and accurate maintenance of study records, while demonstrating advanced communication, leadership, multitasking, and regulatory knowledge.

As an Embedded Systems Architect at Digital Health Solutions, you will play a key role in leading the design and development of embedded hardware and firmware systems, focusing on microcontroller and microprocessor-based solutions. With our expertise in providing end-to-end consulting for medical device product development, including regulatory services, your contributions will be essential in ensuring compliance and quality while guiding development teams through full product lifecycles. Your responsibilities will include: - Architecting and overseeing the development of embedded systems utilizing 32-bit microcontrollers and application processors. - Driving the complete product life-cycle ...

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...