934 Usfda Jobs - Page 29

We are seeking a skilled Analyst with hands-on experience in FTIR/Disso/UV/KF/HPLC/GC techniques(Multiple requirements). The candidate should be well versed with Method Development, Method Validation and routine analysis. Required Candidate profile It is on the rolls of Cotecna Life Sciences India Pvt Ltd(Erstwhile Geochem Laboratories) If interested please share profiles on nilesh.kadam@geochem.net.in or any more information call on 9870476784

The Senior Executive QA (Engineering Assurance) will be responsible for executing and reviewing qualification lifecycle documents for GMP equipment, utilities, and facilities. The role includes oversight of URS, DQ, IQ, OQ, and PQ protocols, engineering change controls, risk assessments (FMEA), and periodic requalification activities. This position works closely with Engineering, Validation, Projects, and cross-functional QA teams to ensure timely qualification and regulatory readiness. Key Responsibilities: QA review and approval of qualification protocols and reports (URS, DQ, IQ, OQ, PQ) Oversight on facility, utility, and equipment qualification activities QA support for engineering chan...

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support a...

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support a...

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support a...

Key Responsibilities: In-Process (IP) Responsibilities: Perform line clearance and IP checks during manufacturing and packaging activities. Monitor critical process parameters during granulation, compression, coating, filling, and packing. Verify BMR/BPR entries and ensure Good Documentation Practices (GDP). Collect and test in-process samples as per approved specifications. Report and escalate any deviations, non-conformities, or abnormal observations. Finished Product (FP) Responsibilities: Sample and submit finished product batches for QC testing. Coordinate with the QC department for timely testing and release of finished goods. Ensure FP storage conditions and labeling are as per SOPs. ...

Key Responsibilities: In-Process (IP) Responsibilities: Perform line clearance and IP checks during manufacturing and packaging activities. Monitor critical process parameters during granulation, compression, coating, filling, and packing. Verify BMR/BPR entries and ensure Good Documentation Practices (GDP). Collect and test in-process samples as per approved specifications. Report and escalate any deviations, non-conformities, or abnormal observations. Finished Product (FP) Responsibilities: Sample and submit finished product batches for QC testing. Coordinate with the QC department for timely testing and release of finished goods. Ensure FP storage conditions and labeling are as per SOPs. ...

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support a...

: Job titleBond Analytics Analyst Corporate titleAVP LocationBangalore, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team at ...

: Job Title Regulatory Filtering Analyst LocationJaipur, India Role Description Regulatory Operations is responsible for defining and implementing procedures which provide regulatory operations services for various divisions of the bank and its group entities. This is to support the bank in its efforts to ensure regulatory compliance. Work includes: Partnering with the banks regulatory team to translate regulation into operational processes/procedures assisted Developing the banks information technology infrastructure Developing and implementing regulatory strategies, procedures and controls for new products and/or business activities that require governmental approvals Preparing and submitt...

Roles and Responsibilities Prepare dossiers for regulatory submissions, including variations, renewals, and rejections. Review DMFs, CMCs, USDMFs, ASMFs, EDQMs, LOAs, QMS documents for accuracy and compliance with regulations. Coordinate with internal teams to gather necessary information for regulatory submissions. Ensure timely submission of applications to relevant authorities in various markets (US, Europe). Maintain records of all submitted documents and follow up on their status.

Knowledge and Skills Working knowledge of 510(k) submissions, EU MDR 2017/745, MDSAP, EN ISO 13485, and 21 CFR 820 - Quality System.

Veeva Vault RIMS L2 Support having 3-5 years of experience in RIMS. Veeva certification will be added advantage. The resource may have to work in CET timezone for initial few months. Client interview will be held post initial selection.

1. Compilation of Post Approval requirements i.e. Annual Reports, CBE-0, CBE-30, PAS, 15-Day Alert Report, PADER etc., ensuring that quality standards are met and submissions meet strict deadlines. Provident fund Office cab/shuttle Health insurance Annual bonus

1. Utilize a broad understanding of cGMP to provide QA support, mentoring and coaching for Operations, Analytical, Logistics and Engineering departments to assure that activities are undertaken in compliance with cGMP and procedures, as appropriate. Required Candidate profile GMP PRO/DATA NIJNA/BMR/ANNUAL PRODUCT REVIEW/MBR/CLEANING VALIDATION

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Regulatory Affairs Specialist-II Careers that Change Lives Career growth and development is about learning and stretching yourself to grow your expertise and navigate your career. Medtronic offers award-winning programs to accelerate your development and growth. Our size, scope and market leadership give you the chance to explore career opportunities and grow as we grow. A Day in the Life Supporting Design and Development Control activ...

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 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 Embedding digital transformation in healthcare operati...

Strong knowledge of cGMP regulations, quality management systems, and industry best practices. Exposure to international regulatory inspections like USFDA, EDQM. Exposure to international regulatory inspections like USFDA, EDQM Required Candidate profile Bachelor’s degree in pharmacy or master’s degree in chemistry from a recognized university.6-9 years of experience in quality assurance roles within the pharmaceutical or API manufacturing industry.

Role & responsibilities Lead and manage the Engineering department with a focus on Process Engineering and Utilities. Plan, design, and implement engineering systems to support sterile and non-sterile pharmaceutical manufacturing. Ensure uninterrupted operation and compliance of all utility systems including HVAC, WFI, clean steam, compressed air, chilled water, and effluent treatment. Develop and implement SOPs for engineering operations, preventive maintenance, and calibration. Ensure compliance with cGMP, GEP, and regulatory requirements for all engineering activities. Lead capital projects including facility upgrades, equipment installation, and utility expansions. Coordinate with QA, Pr...

Review DCS alarms. Ensure that batch charging and other manufacturing operations are strictly in accordance with the BMR/SOP and align with current GMP practices. Maintain manufacturing records online, ensuring compliance with data integrity practices. Collect samples of intermediate/in-process materials and send them to the IPQC/QC lab. Enter and verify production-related inputs in the SAP system. Review and ensure the generation of PISCADA reports. Transfer finished goods using the "Finished Goods Transfer Note." Monitor and ensure minimum stock levels of consumables, logbooks, and status labels. Ensure preventive maintenance of all equipment according to the schedule. Coordinate with serv...

Job Purpose: Maintain compliance to Quality Management System to deliver consistent quality medical devices to fulfil future strategy of Cipla. To Lead and establish Quality Management System for medical devices as per EU Regulatory requirements, CDSCO and ISO 13485 requirements and develop and implement documentation such as SOPs, Quality manual etc. to define the framework. Monitor effective implementation of Quality System across function and appraise Management Representative. Responsible for monitoring metrics/KPI for medical devices starting from design, manufacturing, postproduction. Compile data for management review meetings. Responsible for coordinating with cross functional team f...

To support and execute end-to-end regulatory documentation and review for site transfer projects, from data collation to submission. Key Responsibilities: Coordinate data collection from CFTs for pre submission and site transfer packages. Review all plant-related documents Prepare and submit dossiers for product registrations in Europe, US, UK, Canada, Australia, Brazil markets, ensuring adherence to country-specific guidelines and requirements. Prepare and maintain regulatory trackers. Support query responses and internal audits related to site transfers. Ensure documentation quality and compliance with ICH/FDA/EU/Health Canada guidelines. Qualifications: M. Pharm with 48 years of RA experi...

Manager / Sr. Manager Regulatory Affairs (US Team) Reports To: Head – Regulatory Affairs Market: US and EU Location: Vadodara Job Purpose: To lead site transfer regulatory activities, ensuring timely compilation, review, and submission of ANDA variations, change controls, and query responses to health authorities like USFDA, EU and Health Canada. Responsibilities: 1. Regulatory Submissions and Approvals: Prepare Review and submit dossiers for product registrations and post approval changes in US or Europe markets, ensuring adherence to country-specific guidelines and requirements. Coordinate with internal departments (R&D, Quality Assurance, Production) to compile the necessary technical doc...

Job Role: Junior/ Assistant Associates Manufacturing (Injectables) Eligibility criteria: Qualification: Any Diploma/ BSc (Full time) Years of Experience: 1 to 6 Years should be from injectable manufacturing plant. Job Description Operate production equipment such as Injectable , Sterile , Parenteral machines, Vial / Ampoule filling , Capping , Compounding , Washing ,Sealing, Terminal sterilization, Stopper process & Visual inspection. Monitor and control the production process to ensure quality products are produced within specified parameters. Maintain accurate records of production data and perform routine maintenance tasks on equipment as required. Collaborate with other team members to r...

Job Description: Degree in mechanical engineering, electrical engineering, applied sciences or a related discipline; 10+ years of professional experience in medical device in Risk management , regulatory Quality systems EU MDR, US FDA and closely working R&D, Regulatory Affairs & design quality organizations Strong proven experience in simplifying/reviewing RMM,BRD, RMF, Trace matrix, DHFs, Design requirements, IFUs, Risk management , V&V activities etc. Expertise in interpreting & implementing various medical device standards and guidance's, such as IEC , ISO. Experience with systems for quality management, product development, and follow-up of procedures Knowledge and application of medica...