679 Fda Jobs - Page 18

JD: Key Responsibilities: Design and develop embedded systems for medical devices, ensuring compliance with industry standards (e.g., ISO 13485, IEC 62304, FDA regulations). Work on hardware/software integration, firmware development, and embedded software for medical device products. Develop and implement system-level architecture and embedded software for medical devices, focusing on real-time performance, reliability, and security. Write efficient, maintainable, and high-quality code in C/C++ for embedded systems. Work closely with hardware engineers to integrate sensors, microcontrollers, and other components into embedded systems. Perform hardware and software debugging and testing, inc...

As an experienced SAP QM Consultant joining our team, you will be responsible for implementing, configuring, and supporting SAP QM solutions. Your primary tasks will include designing and configuring quality management processes, integrating SAP QM with other modules, customizing reports and analytics, and troubleshooting technical issues. Collaboration with stakeholders to comprehend business requirements and staying updated with SAP QM innovations will also be crucial. You should possess a minimum of 7 years of experience in SAP QM implementation and support, with a deep understanding of SAP QM architecture and functionality. Proficiency in SAP QM configuration, quality management processe...

Description Regulatory Associate (EU Market) Homebased Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem ...

Role: Medical Writer Shift: Rotation Shift Location: Chennai WFO In this role you will be responsible for: Developing high-quality, scientifically accurate medical and regulatory documents, including clinical study reports, protocols, brochures, and more. Creating clear, concise, and audience-appropriate medical content for healthcare professionals, regulatory agencies, and internal stakeholders. Conducting thorough research and literature reviews to ensure content accuracy and compliance with industry standards. Collaborating with subject matter experts, scientists, and regulatory teams to develop compelling and compliant medical writing materials. Adhering to client and regulatory guidelin...

About The Role : Job TitleRegulatory Control Analyst Corporate TitleAssociate LocationBangalore, India Role Description The candidate for the AFC Centre of Excellence for KYC is supporting CB and IB KYC escalations to AFC, collaborating with the relevant Business stakeholders, Client Lifecycle Management and other AFC functions. Primary focus of the reviewer would be to ensure they review and approve the risk factor highlighted by CLM team as part of NCA/EDR/PRs Organization Deutsche Bank (DB) is committed to the highest standards of Anti-Money Laundering (AML), Sanctions & Embargoes, Anti-Bribery and Corruption (ABC) and Anti-Fraud & Investigations (AF&I) and wider Financial Crime (collecti...

Job Summary: We are seeking a meticulous and detail-oriented Quality Checker to join our packaging artwork team. The role requires thorough experience in reviewing packaging artworks for compliance, consistency, and accuracy. The ideal candidate should be familiar with Adobe Creative Suite tools and artwork validation workflows in regulated industries like pharmaceutical or CPG/FMCG domains. Role & responsibilities Verify packaging artwork files against technical briefs, regulatory standards, and brand guidelines. Check alignment, font consistency, spelling, and layout accuracy in Illustrator and InDesign files. Compare artwork revisions using visual comparison tools or side-by-side manual m...

Key Responsibilities: Drive technical aspects of new business acquisition from customers, including requirement analysis, technical presentations, and feasibility assessments. Engage directly with clients, technical experts, project managers, and internal teams to gather inputs and ensure aligned project scoping and cost modeling. Lead the end-to-end product development lifecycle from prototyping and testing to pilot production, verification, and validation. Collaborate with design, quality, regulatory, and manufacturing teams to ensure successful transfer of products from concept to commercialization. Evaluate technical risks and propose mitigation strategies throughout the development proc...

The primary objective of the role is to facilitate timely approvals from FDA (Loan License units) by effectively collaborating with internal stakeholders and FDA teams to submit various applications. It also involves establishing strong relationships with external stakeholders and engaging in advocacy efforts to support licensing approvals for Cipla LL products. Responsibilities include: - Ensuring timely Regulatory Approvals from State FDA and CDSCO offices for loan license units by following up and obtaining approvals for various applications such as fresh loan licenses, Additional product permissions, Test Licenses, India Business Tender Certificates, WHO-GMP, COPP, State FDA NOC for new ...

The responsibilities of this role include assuring quality care by adhering to standards set by physicians, providing care education to patients in person or over the phone, and following compliance guidelines such as OSHA, FDA, and HIPAA throughout processes. The ideal candidate will be responsible for recognizing patient needs and prioritizing them alongside physician's needs. Qualifications for this position include being a Registered Professional Nurse with current licensure, holding CPR, ACLS, and BCLS certifications, having knowledge of OSHA, FDA, and HIPAA compliance, and being able to lift and position patients on endoscopy stretchers and transport them.,

Approving all Specifications, Test Methods, and Batch Process and Control Records (BMRs). approving validation protocols and reports, and conducting the General Good Manufacturing Practices (GMP) training.

The Documentation Engineer will be a key member of the execution team, responsible for managing and maintaining documentation related to installation, commissioning, qualification of process and utility equipment

Execution & documentation of cleaning validation Protocol review IQ/OQ/PQ Swab & rinse sampling Regulatory audit support Coordination with cross-functional teams

Roles: 1.Production Planning & Operations 2. Quality & Investigations 3. Engineering Store & Waste Management Minimum 5–8 years in a similar role within the Excipient/MCC industry. Strong understanding of GMP and FDA requirements. CTC: upto-10 LPA

Roles: 1.Production Planning & Operations 2. Quality & Investigations 3. Engineering Store & Waste Management Minimum 5–8 years in a similar role within the Excipient/MCC industry. Strong understanding of GMP and FDA requirements. CTC: upto-10 LPA Required Candidate profile Education Required: B.Sc / B.Tech / B.Pharm / B.E. (mandatory) M.Sc / M.Pharm (preferred)

The Plant Manager will play a crucial role in overseeing all operational aspects of a natural product extraction and food processing facility. Your responsibilities will encompass managing production, quality control, maintenance, and distribution to ensure compliance with safety regulations and operational efficiency. Your pivotal role in achieving productivity, cost-effectiveness, and continual improvement in plant operations will be instrumental in upholding the highest standards of food safety and product quality. In terms of Production & Operations Management, you will be tasked with supervising daily operations to facilitate smooth and cost-effective production aligned with organizatio...

You will be responsible for developing, customizing, and maintaining applications for Oracle's JD Edwards management system to meet the specific requirements of clients. Your role will involve analyzing requirements, designing solutions, and utilizing appropriate development tools. It is essential to have 5-7 years of experience in participating as a developer for Oracle's JD Edwards ERP software, including implementations and migrations. You will be expected to conduct technical analysis of functional requirements, develop customized applications and solutions, and create localizations based on new legal resolutions. Your responsibilities will also include designing, developing, and customi...

Familier with testing of Lubricants Greases speciality oils waxes solvents etc responsible for inspection of raw materials in process material and finished products participate in internal safety audit calibration of instruments Providing training to new employee regards quality maintain documents in compliance with quality for production process good analytical capability and patiencenew preparation SOPs BMR amd Filled documents control of RM/PM/Bulk/ FG testing and Release in time handling instruments etc

Skill required: KYC Screening - Sanctions Screening Designation: Regulatory Compliance Analyst Qualifications: BCom Years of Experience: 3 to 5 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Help clients transform their compliance function from reactive to proactive thr...

Responsibilities: * Manage regulatory affairs portfolio from pre-clinical to post-market. * Ensure compliance with FDA, CDSCO & vendor management. * Collaborate on product development life cycle.

Role & responsibilities Strong knowledge of blood banking procedures, including blood collection, processing, testing, and storage. Proficiency in operating and maintaining laboratory equipment, such as centrifuges, refrigerators, and blood typing devices. 3. Excellent attention to detail and ability to accurately interpret laboratory test results. Knowledge of laboratory safety protocols and ability to adhere to strict guidelines to prevent accidents or contamination. Proficiency in using computer systems and software for data entry and record keeping. Willingness to stay updated with advancements in blood banking technology, procedures, and regulations. Strong organizational and time manag...

As an Executive / Senior Executive in Quality Control (QC), you will play a crucial role in ensuring that products consistently meet the defined quality standards of the company. Your responsibilities will include conducting quality testing of raw materials, in-process, and finished products as per Standard Operating Procedures (SOPs). It will be your duty to identify, document, and escalate any non-conformities or deviations found during testing, while maintaining thorough and accurate records of test results, logs, and batch documents. Your role will also involve ensuring alignment with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory requi...

Role & responsibilities Lead end-to-end project management for IT/technology initiatives in the pharma/life sciences domain, ensuring timely delivery and within budget. Collaborate with cross-functional teams including R&D, Quality, Manufacturing, Regulatory, and Commercial teams. Define project scope, objectives, deliverables, milestones, and timelines. Manage vendor coordination, software implementation, system integration, and infrastructure deployments. Ensure alignment of projects with industry regulations such as GxP, CFR Part 11, HIPAA, GDPR, etc. Prepare detailed project plans, status reports, risk mitigation strategies, and issue logs. Act as a single point of contact for stakeholde...

SUMMARY Sr. Site Reliability Engineer Keep Planet-Scale Systems Reliable, Secure, and Fast (On-site only) At Ajmera Infotech , we build planet-scale platforms for NYSE-listed clients from HIPAA-compliant health systems to FDA-regulated software that simply cannot fail. Our 120+ elite engineers design, deploy, and safeguard mission-critical infrastructure trusted by millions. Why You’ll Love It Dev-first SRE culture automation, CI/CD, zero-toil mindset TDD, monitoring, and observability baked in not bolted on Code-first reliability script, ship, and scale with real ownership Mentorship-driven growth with exposure to regulated industries (HIPAA, FDA, SOC2) End-to-end impact own infra across De...

Overseeing the networks, servers, and operating systems to ensure seamless functionality, stability, and high performance across all sites, including managing legacy systems and integrating new technologies like IoT and cloud solutions. Leading the implementation of IT projects, including system upgrades, migrations, and new technology rollouts, ensuring they are completed on time, within scope, and within budget. Collaborating with senior management to develop and execute the IT strategy, identifying and recommending technology solutions to improve operational efficiency, production processes, and business growth within the manufacturing environment. Ensuring compliance with relevant indust...

Objectives Of The Position Responsible for Regulatory strategy of South Asia, ASEAN, ANZ (close collaboration with strategic Regulatory management team) Responsible for all compliance activities in South Asia, ASEAN, ANZ Responsible for all registration activities in South Asia, ASEAN, ANZ Consolidate and communicate prioritization of product registrations and regulatory submissions Provide customer support beyond BASF for end users, supporting customers in preparation of drug product submissions and responses to deficiency questions from Health authorities Consolidate and communicate development in the South Asia, ASEAN, ANZ regulatory environment Regulatory representative for BASF Pharma i...