669 Fda Jobs - Page 2

Responsibilities: Review and approve batch records, laboratory data, and other relevant documents related to the manufacturing process. Ensure all operations comply with GMP guidelines, FDA documentation requirements, and internal quality standards. Conduct internal audits to assess adherence to GMP, standard operating procedures (SOPs), and other regulatory requirements. Participate in the review and approval of finished product batch records and assist in product release processes. Investigate and manage deviations, CAPAs (Corrective and Preventive Actions), and OOS (Out of Specification) results in a timely manner. Support the Quality Control Laboratory to ensure all testing is performed ...

Job Description As a Mechanical Architect in our S&RC business unit, you will support remediation, relaunch (MLD), Sustenance and NPI activities and l ead mechanical architecture and design for CPAP/BiPAP devices (Dream Station 1 & 2), driving product lifecycle activities including Modify Launched Design (MLD), PDLM, and CAPA. Collaborate across functions and suppliers to deliver robust, compliant, and innovative solutions. Key Responsibilities Lead design changes and MLD activities for Sleep therapy devices. Define and maintain modular, scalable mechanical architecture. Ensure safety, reliability, and performance compliance. Drive technical roadmap, feasibility studies, and innovation. Guid...

Ways of working : Mandate 3 - Employees will come to the office everyday at their base location. About Swiggy Instamart: Swiggy Instamart, is building the convenience grocery segment in India. We offer more than 30000 + assortments / products to our customers within 10-15 mins. We are striving to augment our consumer promise of enabling unparalleled convenience by making grocery delivery instant and delightful. Instamart has been operating in 90+ cities across India and plan to expand to a few more soon. We have seen immense love from the customers till now and are excited to redefine how India shops. Position: Assistant Manager - Regulatory (Private Label Business) Function: Regulatory & Co...

Ways of working : Mandate 3 Employees will come to the office everyday at their base location. About Swiggy Instamart Swiggy Instamart, is building the convenience grocery segment in India. We offer more than 30000 + assortments / products to our customers within 10-15 mins. We are striving to augment our consumer promise of enabling unparalleled convenience by making grocery delivery instant and delightful. Instamart has been operating in 90+ cities across India and plan to expand to a few more soon. We have seen immense love from the customers till now and are excited to redefine how India shops. Position: Assistant Manager Regulatory (Private Label Business) Function: Regulatory & Complia...

Sphera is a leading global provider of enterprise software and services that enables companies to manage and optimize their environmental, health, safety and sustainability. Our mission is to create a safer, more sustainable and productive world. Sphera is a portfolio company of Blackstone, a U.S.-based alternative asset investment company that focuses on private equity, technology and innovation, and more. Blackstone businesses succeed through strong partnerships, a personalized approach and a commitment to exceptional performance with uncompromising integrity. Sphera and Blackstone are leaders in the Environmental, Social and Governance (ESG) space. We are guided by our core values of Cust...

JOB DETAILS 1.Should have sound knowledge of FDA documentation (Domestic and Exports). 2.Should have multi-tasking attributes and should have excellent communication skills to interact with FDA authorities / Overseas Customers. 3.Should be able to plan and execute the FDA activities as per requirements and should be flexible to manage the priorities. 4.Should be well versed with requirements / guidelines of local and other state s FDA authorities. 5.Should have enough knowledge and experience of coordinating with FDA for new applications / renewal of applications pertaining to Loan mfg. license, NOC s, Test Licenses, Product Permissions, COPP, FSC, NSQ, WHO-GMP and other technical documents....

JOB DETAILS 1. Responsible for smooth production activity in Liquid Oral / tablet section (Dispersible Tablet and Film coated tablets) and Dry Syrup Section in Cephalosporin Section ( Oral Dosage Form) 2. Responsible for optimum utilization of installed capacity 3. Manufacturing Chemist FDA Approved in Liquid Oral 4. Maintain documentation of as per FDA requirements 5. Carrying out day to day activities related to manufacturing 6. Taken plant round and compliance the GMP 7. To check the Equipment for execution of the batch 8. Coordination with different support departments for smooth running of plant 9. Control the process, reaction as per written procedure 10. Following cGMPs and other stat...

JOB DETAILS 1)Needs to ensure that most of the safety reports that are received from the investigational sites or from the post- marketing sector must be identified & reported in accordance to the ICH-GCP standards & also by the standard operational procedures. 2)Reports that are collected must be organized based on the seriousness or effectiveness of the drug initially. 3)An overall consistency in assessing the adverse reaction reports must be accurate & legible. 4)Must be judgmental in taking appropriate decisions by applying their knowledge of FDA & ICH-GCP standard regulations. 6)Must be able to communicate with clinical physicians in drug safety and assess case report forms. 7)Must be a...

We are seeking a detail-oriented and experienced Manager, Quality Assurance to lead our QA team and ensure the highest standards of quality across products, processes, and services. The QA Manager will be responsible for developing and implementing quality assurance policies, conducting audits, analyzing data, and collaborating with cross-functional teams to drive continuous improvement. Key Responsibilities: Lead and manage the Quality Assurance team, including hiring, training, and performance management. Develop, implement, and maintain QA standards and procedures in accordance with regulatory requirements and best practices. Monitor and report on quality metrics, identifying areas for im...

Job Title Mechanical Architect Job Description As a Mechanical Architect in our S&RC business unit, you will support remediation, relaunch (MLD), Sustenance and NPI activities and l ead mechanical architecture and design for CPAP/BiPAP devices (Dream Station 1 & 2), driving product lifecycle activities including Modify Launched Design (MLD), PDLM, and CAPA. Collaborate across functions and suppliers to deliver robust, compliant, and innovative solutions. Key Responsibilities Lead design changes and MLD activities for Sleep therapy devices. Define and maintain modular, scalable mechanical architecture. Ensure safety, reliability, and performance compliance. Drive technical roadmap, feasibilit...

Overseeing daily production to ensure efficiency and quality, managing and developing a production team Ensuring compliance with all pharmaceutical regulations, such as GMP and safety standards Develop and manage schedules to achieve Prod. target Required Candidate profile B. Pharma - M. Pharma- M.Sc Minimum 10 years experience in Formulation, Cosmetics Beauty Care , Personal Care Manufacturing Company Must capable to Manage All Production And Administrative Affairs

QC Microbiologist API / Pharmaceutical Formulation Industry Location: Boisar / Tarapur, Maharashtra Experience: 2 to 7 Years Salary Range: 2.5 LPA 4.5 LPA Industry: API / Pharmaceutical / Healthcare / Formulation Manufacturing Department: Quality Control (Microbiology) Employment Type: Full-Time Joining: Immediate or within 15 Days About the Company: A reputed pharmaceutical and API manufacturing organization engaged in the production of active pharmaceutical ingredients and healthcare formulations . The company focuses on quality, regulatory compliance, and advanced microbiological practices , offering excellent opportunities for professional growth. Job Role & Responsibilities: Perform Mic...

Key Responsibilities Provide quality support to design and development teams. Review and approve design control documents (DHF, DMR, Risk Management File). Ensure compliance with ISO 13485, ISO 14971, and applicable regulatory standards. Participate in design reviews and risk assessments. Support verification, validation, and design transfer activities. Drive continuous improvement in design quality processes. Collaborate with cross-functional teams (R&D, Regulatory, Manufacturing, and Post-Market). Qualifications Bachelor’s degree in Mechanical Engineering or related field. 7+ years’ experience in Design/Development Quality in the medical device industry. Strong understanding of ISO 13485, ...

Roles & Responsibilities Manage and maintain the QMS, ensuring compliance with global medical device regulations. Lead internal and external audits; ensure timely closure of findings. Oversee document control, CAPA, training, and change management processes. Monitor quality metrics and drive continuous improvement initiatives. Support regulatory inspections, product registrations, and management reviews. Collaborate with cross-functional teams to ensure quality integration in all processes. Train and mentor team members on QMS requirements and best practices. Qualifications Bachelor’s/Master’s in Engineering, Mechanical or related field. 7+ years’ experience in Quality Assurance, with 3+ yea...

You will be joining our Global Application Maintenance and Support team as a JDE Developer. Your role will involve supporting and enhancing JD Edwards applications and interfaces. To excel in this position, you will need a strong technical background, top-notch problem-solving skills, and the ability to collaborate effectively with a global team. **Key Responsibilities:** - Provide ongoing support, maintenance, and enhancements for JDE Applications. - Troubleshoot and resolve application issues promptly. - Collaborate with cross-functional teams to gather requirements and implement new solutions. - Participate in code reviews, testing, and deployment activities. - Ensure application performa...

As a Software Developer you'll participate in many aspects of the software development lifecycle, such as design, code implementation, testing, and support. You will create software that enables your clients' hybrid-cloud and AI journeys. Your primary responsibilities include Comprehensive Feature Development and Issue Resolution, Stakeholder Collaboration and Issue Resolution and Continuous Learning and Technology Integration Required education Bachelor's Degree Preferred education Master's Degree Required technical and professional expertise Installation, configuration and maintenance of JD Edwards EnterpriseOne environments including tools releases, ESUs, ASUs, and application updates. Ma...

Support and Maintenance of customers Adobe Campaign Classic platform Responsible for handling tickets in Production environment Perform RCA on recurring issue and provide permanent fixes Monitoring of the workflow and taking corrective actions Coordination of system-related activities between user and multiple technical teams Responsible for the upkeep and maintenance of Adobe Campaign application servers and coordination with DBA"s Understanding integration of Adobe with other applications. Primary Skills 4 to 5 years of support and development experience with Adobe Campaign Classic (Neolane) Experience in working with different Adobe Campaign modules, like; Message Centre, Content Manager,...

Job Description Job Overview: We are currently seeking a highly skilled and experienced JDE Developer to join our Global Application Maintenance and Support team. The ideal candidate will be responsible for supporting and enhancing JD Edwards applications and interfaces. This role requires a strong technical foundation, excellent problem-solving skills, and the ability to collaborate effectively within a global team environment. Responsibilities Key Tasks and Responsibilities: Provide ongoing support, maintenance, and enhancements JDE Applications. Troubleshoot and resolve application issues in a timely manner. Collaborate with cross-functional teams to gather requirements and implement new ...

Your role and responsibilities As a Software Developer you'll participate in many aspects of the software development lifecycle, such as design, code implementation, testing, and support. You will create software that enables your clients' hybrid-cloud and AI journeys. Your primary responsibilities include Comprehensive Feature Development and Issue Resolution, Stakeholder Collaboration and Issue Resolution and Continuous Learning and Technology Integration Required education Bachelor's Degree Preferred education Master's Degree Required technical and professional expertise Installation, configuration and maintenance of JD Edwards EnterpriseOne environments including tools releases, ESUs, AS...

Work Flexibility: Hybrid Who we want: Passionate & Goal-oriented Engineers: Passion for excellence in technology. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions. Analytical problem solvers: People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues. Dedicated achievers: People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. Self-Driven Curious learners: People who take initiative and hold themselves accountable. People who seek out for cutting-edge research and in...

Who we want: The Tools Administrator will assist in the ongoing adaptation and deployment of new tools such as JAMA Windchill/ DOORS. The administrator will work closely with functional leaders, organizational units, and subject matter experts to identify develop and deploy new business processes. This role is part administrator, part quality analyst and part trainer. The Administrator will be responsible for executing on the day-to-day configuration, support, maintenance and improvement of the tools, qualification of the tools and associated processes. The Administrator will manage the relationship with the software vendors and be responsible for documenting and updating internal processes ...

Role & responsibilities Responsible for ensuring and carrying out tasks in accordance with FDCA, CDSCO and Prohibition Excise guidelines. Responsible for preparing the ACDF application, i.e. CoPP, renewal and new manufacturing licences. Responsible for WHO GMP, Additional Product Permission, Tender Certificate, Test License Technical person approval Responsible for preparing wholesale license, loan license, audit, and inspection reports. Responsible for preparing IT application at CDSCO i.e. Test License, Form 10, From 11, Import & Export NOC Responsible to ensure and prepare renewal of licence for prohibition and excise. Also took necessary approval for Naukarnama and do return submission a...

Responsibilities: Experience in Method Validation. Experience in Stability Study. Experience of review Electronic data review and backup systems. Expert in Qualification of analytical instruments like HPLC, GC, AAS, FTIR, UV etc. Expert in Calibration of analytical instruments like HPLC, GC, AAS, FTIR, UV etc. Must have minimum 3+ years of experience as a Reviewer. Must have an experience of reviewing all types of QC software. Must be familiar with cGMP/GLP practices and ICH and FDA Guidelines. Required Skills Must be excellent in written and spoken English; net savvy and adept at computer skills. Logical thinking. Organizing. Good in communication. Required Qualification: - B.Sc/M.Sc - Chem...

Responsibilities: Review and approve batch records, laboratory data, and other relevant documents related to the manufacturing process. Ensure all operations comply with GMP guidelines and internal quality standards. Conduct internal audits to assess adherence to GMP, standard operating procedures (SOPs), and other regulatory requirements. Participate in the review and approval of finished product batch records and assist in product release processes. Investigate and manage deviations, CAPAs (Corrective and Preventive Actions), and OOS (Out of Specification) results in a timely manner. Support the quality control laboratory in ensuring that all testing is performed in accordance with regulat...

Coordinate regulatory submissions and ensure compliance with relevant laws and regulations.Prepare and review regulatory documents, including applications and reports.Collaborate with cross-functional teams to meet regulatory requirements. Required Candidate profile Strong knowledge of employment firms and recruitment services.Excellent communication and coordination skills.Ability to work effectively in a fast-paced environment.