397 Fda Jobs - Page 7

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...

As a global leader in assurance, tax, transaction, and advisory services, we at EY are dedicated to hiring and nurturing the most passionate individuals in their respective fields, all in an effort to contribute towards creating a better working world. Our culture is rooted in the belief that every individual deserves the training, opportunities, and creative freedom essential for growth. At EY, we are not solely interested in your current capabilities, but in the potential of who you can become. We firmly believe that your career is yours to shape, with limitless possibilities awaiting you. Throughout your journey with us, we are committed to providing you with inspiring and fulfilling expe...

Are you passionate about driving clinical quality and compliance Do you have a proven track record in clinical operations and a knack for innovation and process improvement If you're ready to take on a leadership role that makes a real impact, we invite you to explore this exciting opportunity, apply today for a life-changing career! As the Head of Clinical Operational Excellence, you will play a pivotal role in ensuring clinical quality, compliance, and operational excellence. Your key responsibilities will include performing risk assessments and trend analyses to proactively address clinical quality risks, ensuring audit and inspection readiness including CAPA documentation and stakeholder...

Function:PMSRole:Post Market SurveillanceDesired Skills:PMS, complaint handlingCreate PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis Risk management Risk assessment. Required Candidate profile Propose strategies and solutions to data issues or challenges that occur during the PSUR writing and conclusion process.

Hiring for the role of Documentation Job Title: Documentation Level Executive / Sr. Executive Experience: 3-5 Years Location: Ankleshwar Job Summary: The Documentation Engineer will be a key member of the execution team, responsible for managing and maintaining documentation related to installation, commissioning, and qualification of process and utility equipment. This role is ideal for mid-level professionals (3-5 years of experience) looking to advance their expertise in installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for equipment used in pharmaceutical, chemical, and food processing industries. Key Responsibilities: Prepare and maintai...

Responsible for manufacturing of all types of Tablet / Capsule / Powder (FDA Approval Must) Responsible for timely delivery with Quality and Quantity Responsible for motivation and handling of manufacturing workforce New Product Development Conduct Technical Non Technical Trainings Manufacturing of Tablet Capsules (Ayurvedic Allopathy) Predict, handle and rectify manufacturing defects Man management skills Knowledge of GMP guidelines Efficient in Documentation 2 - 3 Yrs at junior / executive position of similar profile

You will be working as a Manufacturing Operator in the Pharma Solution business unit within the Operations department located in Lexington. Your primary responsibilities will include performing various production activities such as component preparation, filling, capping, autoclaving, compounding, and lyophilization production. You will report directly to the Manufacturing Supervisor. In this role, you will be required to comply with all relevant policies and procedures set forth by PPS and various regulatory agencies. Some of your key responsibilities will involve performing line clearances, cleaning and sterilization of equipment, operation of aseptic filling equipment, executing validatio...

As an Analytical Chemist at Linde, you will utilize your knowledge of Quality control and GMP under FDA guidelines to ensure targets are met and plant parameters are optimized for maximum output and efficiency. Your role will involve ensuring compliance with local regulations and obtaining necessary approvals/licenses, particularly from the FDA. You will also play a key role in selecting suitable suppliers, agreeing on technical scope/solutions, conducting stage gate inspections for quality assurance, and assessing technical competency to assign tasks accordingly while ensuring safety and quality standards are maintained. Additionally, you will be responsible for making purchases for materia...