940 Usfda Jobs - Page 35

Vibonum Technologies Private Limted conducting a Walk-in interview for Production Supervisors and Production Officer for its OSD Plant at Mysore. Production Supervisor: Total Vacancies - 40, Education: B. Pharm / M. Pharm Exp: 5 Years and above Production Officer Total Vacancies - 40, Education: Diploma / ITI Exp: 5 Years and above Work Location: Nanjangud Mysore Walking Address: Sai Vishram Business Hotel, Hebbagodi, 144-C/1, Kirloskar Road, opp. MTR, Bommasandra Industrial Area, Bommasandra, Bengaluru, Karnataka 560099 Google Map: https://maps.app.goo.gl/Pkh8ASL1JFpJv2An8

Skill required: Property & Casualty - Property and Casualty Insurance Designation: Insurance Operations Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years What would you do? We help insurers redefine their customer experience while accelerating their innovation agenda to drive sustainable growth by transforming to an intelligent operating model. Intelligent Insurance Operations combines our advisory, technology, and operations expertise, global scale, and robust ecosystem with our insurance transformation capabilities. It is structured to address the scope and complexity of the ever-changing insurance environment and offers a flexible operating model that can meet the u...

Job Description: Quality Assurance Manager Location: Madhapur, Hyderabad Employment Type: Full-Time Job Summary The Quality Assurance Manager will oversee quality assurance processes for our clinical trial software and AI systems, ensuring compliance with global regulatory requirements, including USFDA (21 CFR Part 11), GDPR, HIPAA, ICH-GCP, ISO 90001 & 27001 and other relevant standards. This role requires deep expertise in Computer System Validation (CSV). With 10+ years of experience, the ideal candidate will lead a QA team, collaborate with cross-functional groups, and drive continuous improvement to deliver reliable, compliant, and innovative solutions. Key Responsibilities of a Quality...

We are seeking a skilled Analyst with hands-on experience in HPLC or GC or ICP techniques. The candidate should be well versed with Method Development, Method Validation and Method Transfer. 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

Job Summary We are looking for a detail-oriented engineering team member to coordinate preventive maintenance schedules, manage breakdown records, and ensure adherence to SOPs, critical for maintaining operational efficiency and equipment reliability. This role plays a pivotal part in inventory control, and CAPA closure, contributing to seamless production operations, compliance with regulatory standards, and effective resource utilization. Roles & Responsibilities • To maintain the facility as per cGMP, and GMP requirements of country where product is being exported and strict adherence of Good Engineering practices during task execution. Can handle Water system operation and maintenance. C...

Job Role : ODR Auditor Designation : Manager (G11A)/Sr. Executive ODR Department & Sub Area (If applicable) : Office of Data Reliability (Mohali) Accountabilities: This position is accountable for critically reviewing any data and documents generated in Quality Control Laboratory as well as executed Batch records which are meant for submission to USFDA and ensure the data integrity and accuracy of all documents ready for submission. Ensure during pre-submission review of all data pertaining to submission to USFDA that all Finished products, Drug Substances, Intermediates, Raw materials and Packaging materials are tested as per approved procedures under cGMP conditions and documented precisel...

Job Role : ODR Auditor Designation : Manager (G11A)/Sr. Executive ODR Department & Sub Area (If applicable) : Office of Data Reliability (Gurugram) Accountabilities: This position is accountable for critically reviewing data and documents generated by Analytical Research Department and Product/Packaging development department which are meant for submission to USFDA and ensure the data integrity and accuracy of all documents ready for submission. Responsibility: Perform thorough review of raw data (pertaining to R&D related activities (viz. Analytical Method Validations /Analytical reports / Analytical Method Transfer / Product Development Report etc. ) compiled by respective department & alr...

About The Role The ideal candidate must possess strong communication skills, with an ability to listen and comprehend information and share it with all the key stakeholders, highlighting opportunities for improvement and concerns, if any. He/she must be able to work collaboratively with teams to execute tasks within defined timeframes while maintaining high-quality standards and superior service levels. The ability to take proactive actions and willingness to take up responsibility beyond the assigned work area is a plus. Specialism – KYC, AML, Due Diligence Senior Analyst Roles & responsibilities: Responsible for managing KYC operations for a large Investment Bank Independently handle multi...

About The Role The ideal candidate must possess strong communication skills, with an ability to listen and comprehend information and share it with all the key stakeholders, highlighting opportunities for improvement and concerns, if any. He/she must be able to work collaboratively with teams to execute tasks within defined timeframes while maintaining high-quality standards and superior service levels. The ability to take proactive actions and willingness to take up responsibility beyond the assigned work area is a plus. Specialism – KYC, AML, Due Diligence Senior Analyst Roles & responsibilities: Responsible for managing KYC operations for a large Investment Bank Independently handle multi...

About The Role The ideal candidate must possess strong communication skills, with an ability to listen and comprehend information and share it with all the key stakeholders, highlighting opportunities for improvement and concerns, if any. He/she must be able to work collaboratively with teams to execute tasks within defined timeframes while maintaining high-quality standards and superior service levels. The ability to take proactive actions and willingness to take up responsibility beyond the assigned work area is a plus. Specialism – KYC, AML, Due Diligence Senior Analyst Roles & responsibilities: Responsible for managing KYC operations for a large Investment Bank Independently handle multi...

About The Role : Job titleBond Analytics Analyst Location:Mumbai, India Corporate title Associate 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 Agenc...

About The Role : 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 Se...

Job Title: Senior Regulatory Publishing Specialist Responsibilities: Technical Document Preparation: Lead the preparation, review, and submission of Technical documents/Dossiers (CTD/ACTD) for both Regulatory and Non-Regulatory Markets. eCTD Publishing: Proficiently handle the electronic regulatory submissions (eCTD), ensuring accuracy and compliance with regulatory standards. Submission Build Activities: Execute submission build activities, including creating inter-document links, conducting quality checks, validating compiled submissions, and ensuring timely dispatch. Collaboration with RA - Ops Team: Coordinate and engage with the Regulatory Affairs Operations team to facilitate on-time s...

Walk-in at Matoda We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned. If any of the requirements match your current job profile, kindly walk in with your latest resume. Role & responsibilities QUALITY ASSURANCE IPQA (Injectable), IPQA (OSD) & QMS / Documentation / Validation and Qualification (Officer / Senior Officer / Executive/Senior Executive) Experience - 02 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / M.Sc. Injectable Manufacturing Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years...

What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role is for a technical functional lead/developer with Clinical Risk Based Monitoring (RBM) / Risk Based Quality Management (RBQM) system implementation. The role involves working closely with product managers, designers, and other engineers to build high-quality, scalable software solutions. Roles & Responsibilities: Participate in technical discussions related to the RBSE system(s) within Clinical Trial...

The RA CMC Senior Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Senior Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC Senior Manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. The RA CMC Senior Manager may have staff oversite. ...

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. Key Activities Contributes to product teams and acts as product lead or ...

Roles and Responsibilities Ensure compliance with regulatory requirements from USFDA, GMP, WHO, and other relevant authorities. Conduct internal audits to identify areas of improvement and implement corrective actions. Develop and maintain relationships with regulatory agencies to ensure smooth operations. Provide guidance on Good Manufacturing Practices (GMP) and Current Good Manufacturing Practice (cGMP) guidelines. Collaborate with cross-functional teams to resolve regulatory issues. Desired Candidate Profile 5-10 years of experience in Regulatory Affairs or related field. Strong knowledge of Allopathy or homeopathy regulations and guidelines. Proven track record of handling regulatory au...

Job Position: PMS Service Medical Devices Complaints Handling Job Description: To handle medical device customer allegations in complaints management system . Candidate with knowledge on Medical devices usage, Complaint Evaluation, Investigation, Medical devices reporting including post-market surveillance (PMS) and CAPA. Roles and Responsibilities: To work on Complaint handling Process Evaluation, Regulatory Assessment, Investigation Work with lead in completing daily assignation. Organize and manage daily work allocation Complaints remediation using work instruction, compliance to process To drive efficiency and compliance. Collaborate with of cross function team (CFT) such as Intake, MDR,...

Role & responsibilities Candidate having experience in to OSD pharmaceuticals from QC/QA/Production/F&D/ADL

About Company ReNew is a leading decarbonization solutions provider and the first Indian clean energy company to list on Nasdaq (Nasdaq: RNW). With 16.3 GW of commissioned and pipeline utility-scale projects, we are a global company with strong Indian roots. Founded in 2011, ReNew is at the forefront of fighting climate change by offering decarbonization solutions through utility-scale wind and solar offerings, green hydrogen, carbon markets, and energy storage. ReNew has been a pioneer in leveraging digital technologies to accelerate the transition to green energy and address the unique requirements of the B2B segment in India, where we are the market leader. Our mission is to play a pivota...

We are hiring for a Public listed BSE / NSE - Pharma - API / Crop Protection / Animal Health Intermediates Mfg CDMO / CRAM Company. Role : Team Leader - ADL Title : Sr. Scientist R&D Centre Level : Deputy Manager CTC : Ceiling Rs 15 Lpa Experience: Minimum 14 years to Max 18 years Those working at R&D Centres of Crop Sciences / API / Specialty Chemicals are only eligible. Formulations / Vaccines / Bio labs are not eligible. Formulations Qualification : Full Time M.Sc in Organic Chemistry / Analytical Chemistry only. Those in other specialisation of Chemistry are not eligible. Those with Correspondence Masters degree won't qualify. Location: Pune Saturdays: 2nd / 4th Not working Local Company...

Post: Regulatory -Deputy Manager for a Food processing co at Hosur Preferred Industry: Food/ FMCG/ manufacturing industries (Dairy, Snacks, Spices / Instant Mixes, Masala & Sweets) Qualification: B.Tech/B.E - (Food Processing Engineering/Food Technology/Food Science)/MSc Microbiology A) 7 to 9 years experience in food/FMCG companies. Food/ FMCG/ manufacturing industries (Dairy,Snacks,Spices / Instant Mixes, Masala & Sweets) B)Minimum 2 to 3 years of exposure in USFDA, FSANZ, GSO, FSSAI regulation. C)Should have handled FSMS related audits (FSSC, BRC & IFS). D) Must have completed Lead Auditor course in ISO 22000:2018 / FSSC 22000 /BRCGS-Issue 8/Issue9. E) Able to handle food safety related a...

Role & responsibilities 1. Production Planning and Scheduling 2. Compliance and Documentation 3. Supervision of Manufacturing Processes 4. Personnel Management and Training 5. Quality and In-Process Control 7. Process Optimization and Yield Improvement 8. Regulatory and Customer Audits Preferred candidate profile Education: B.Pharm / M.Pharm / B.Sc with strong domain knowledge in OSD manufacturing. Experience: 15+ years in pharmaceutical production, with at least 5 years in a managerial role overseeing OSD manufacturing. Regulatory Exposure: Hands-on experience in facing WHO-GMP, and other inspections. Skills: Leadership, decision-making, analytical thinking, team management, and strong know...

GCS Medical College Hospital & Research Centre is looking for Executive - Quality to join our dynamic team and embark on a rewarding career journey. Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the l...