299 Cmc Jobs - Page 5

Designation Field Service Engineer Department Service Location Kolhapur,Pune Product Portfolio IVD (In-Vitro Diagnostics) Business Importance of the Role: This role owns delivering service & service business results as per Operational Metrics defined below & meets the operating Business Plan of Genworks. Manages high level of Customer satisfaction through Service Excellence at assigned customer accounts/IB by driving various Operations parameters as per target. Also drive Commercial excellence through AMCs, CMCs, Part Sales, Accessories & Consumable Business time to time. Over a period of time becomes the Customer success leader & be the Point of contact by building strong relationship betwe...

Supervise installation by client, commissioning, training and handover of air compressors & accessories. Maintenance of air compressors through PM, AMC, health check, etc. Problem identification and troubleshooting at customer location. Required Candidate profile Work Experience: 5-10 years of field experience in servicing of industrial machinery or utility department viz. air compressors, generators, blowers, process chillers, electric motors.

Job Description Responsible for submissions of Response to Deficiencies to Health Agencies of Europe, Australia, New Zealand and Canada market and Customers. Responsible for post approval submissions to Europe, Australia, New Zealand and Canada market. To provide Regulatory inputs during inspections by Regulatory authorities and Customer as and when required. To provide Regulatory inputs during product development, manufacturing and testing and to evaluate all types of change proposals during product life cycle Work Experiance Should have worked in Regulatory Affairs Dept for regulated markets like EU/UK, Australia, Canada, US etc (minimum 1-2 years). Submission of new submissions, deficienc...

Role SAP BI/BW +BOBJ Senior Consultant Hiring Location: India (Delhi, Noida, Mumbai, Hyderabad) Responsibilities Document all technical and functional specifications for implemented solutions. Proficient in BW/B4H & ABAP/CDS with experience in the areas of Analysis, Design, Development Collaborate with clients to gather business requirements and translate them into BI/BW technical solutions. Interact with key stakeholders/support members in different areas of BW. Provide technical solutions to fulfil business requests using SAPs BW. Design, develop, configure, migrate, test and implement SAP BW 7.x data warehousing solutions using SAP BW, BW/4HANA, and related tools. Ensure data accuracy, in...

As a Customer Service Associate at Accenture, you will be part of the Healthcare Management team responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. Your role will involve overseeing day-to-day operations, department activities, medical and health services, budgeting, research, education, policies, quality assurance, patient services, and public relations. Your primary responsibility will be to coordinate essential documentation and resources necessary for the filing of global applications related to healthcare operations. This will involve understanding, managing, and processing electronic submissions such as original application f...

About The Role Skill required: Provider Network - Life Sciences Regulatory Operations Designation: Health Operations Associate Manager Qualifications: Any Graduation Years of Experience: 10 to 14 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.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 cl...

Career Category Information Systems Job Description 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. .

Christian Medical College is looking for LIBRARY ASSISTANT to join our dynamic team and embark on a rewarding career journey Assist patrons in locating library materials, including books, journals, multimedia resources, and electronic databases Provide friendly and knowledgeable customer service by answering inquiries, assisting with library technology, and providing basic research assistance Check library materials in and out using the library's automated system, ensuring accuracy and maintaining patron confidentiality Shelving and organizing library materials according to established classification systems, ensuring items are easily accessible to patrons Process new library materials, incl...

Role & responsibilities Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adherence to high quality, and regulatory standards in dossiers. Good interpretation of FDA queries. Meeting agreed upon timelines. Excellent drafting skill. Ensure adherence to high safety, quality, and regulatory standards in response. Evaluation and good interpretation of post approval changes. Submission of supplements like CBE, CBE-30 and Prior Approval Supplement (PAS).Draft high-quality responses to regulatory agency letters (IR, DRL, CR) within stipulated timelines. Evaluate and interpret post-approval changes & Review of Pharmaceutical Development Reports, Review key regul...

Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and evolving global agency standards, CMC RA submission processes, electronic submission regulations and guidance regarding structure requirements to CMC development teams regarding global CTAs and registration dossiers. Responsible for preparing CMC CTD content consistent with approved manufacturing changes, technical reports and procedural requirements. Partner with the CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products. Partner with the CMC RA Sci...

Career Category Regulatory Job Description Job Description: Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and...

Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands company€™s customer base and ensure it€™ s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status

: - Visit the customers for attending to technical jobs viz., repairs, refurbishing etc. - Work as per contracts GMC / PMC / CMC schedules - Support the service business by generation of sales of genuine spares - Customer satisfaction by fast response and quick service (minimum lead time) for long-term relationships. - Salvage the spare parts, understand recurring problems of the products,replacement of spares at customers site and sending back items under warranty to HO for proper accounting and documentation. - Provide training to customers operators about upkeepment, maintenance and safety of the equipment purchased by the customers - Educate and recommend to the customers on new products...

International Solar Alliance is looking for REGULATORY SPECIALIST to join our dynamic team and embark on a rewarding career journey Diagnosing and treating illnesses, medical conditions, and injuries. Ordering, performing, and interpreting diagnostic tests. Collecting, recording, and maintaining patients' information and histories. Prescribing and administering treatments, therapies, medications, vaccinations, and other specialized medical care. Explaining procedures and discussing test results or prescribed treatments with patients and family members. Monitoring patients' conditions and progress. Directing, coordinating, consulting with, and referring patients to nurses, students, assistant...

Primary Skills: SAP UI5 with practical experience in designing and developing UI5 hybrid applications for desktop, SAP provided libraries, AJAX, CSS3, jQuery etc Knowledge of designing and implementing responsive UI5 Application in Split-App using Fiori Design Guidelines Knowledge of implementing Design Thinking Implementation knowledge of standard application configuration and custom Fiori extensions Secondary Skills: Knowledge of OData, CDS and AMDP, SAP HANA and ABAP will be preferable Knowledge of JAVA SDK Knowledge of SAP MII/ME will be added advantage Total Experience Expected: 04-06 years

Career Category Regulatory Job Description R egulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The Regulatory Compliance team is a part of RA CMC and is seeking to expand its capacity in India . The Regulatory Compliance team performs assessment of operational changes for regulatory reportability and maintenance of state and federal licenses for Amgen products across phases of development, modality, and countries. The team member will be respo...

Career Category Regulatory Job Description R egulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The Regulatory Compliance team is a part of RA CMC and is seeking to expand its capacity in India . The Regulatory Compliance team performs assessment of operational changes for regulatory reportability and maintenance of state and federal licenses for Amgen products across phases of development, modality, and countries. The team member will be respo...

Career Category Regulatory Job Description Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The Regulatory Compliance team is a part of RA CMC and is seeking to expand its capacity in India . The Regulatory Compliance team performs assessment of operational changes for regulatory reportability and maintains state and federal licenses for Amgen products across phases of development, modality, and countries. The team member will be responsible...

Career Category Regulatory Job Description 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...

Career Category Regulatory Job Description 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. Key Acti...

Role & responsibilities 1)AMC/CMC of BME equipment 2)BME Inventory management and Medical Gas Management system 3) Calibration of Medical equipment ( Diagnostic & Therapeutic) 4) Thorough knowledge of surgical instruments used in different specialities 5) Able to train the user end about SOPs of medical instruments & equipment Preferred candidate profile

Who We Are Together, were on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives Its a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds Working here means working with the worlds leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organizations Essential Medicines List Today, at least 200 million people around the world take one of our medicines every single day An amazing number, but were always looking for new ways to continue making a difference, and new people to make a difference with, How Youll S...

Perpetuity Capital is looking for AREA SALES MANAGER to join our dynamic team and embark on a rewarding career journey Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products a...

Skills: VisionPlus Knowledge Mandatory Roles & Responsibilities: Working on vision plus Mainframe system (CMS, FAS, LMS, FRAUD) Triaging user tickets and incidents, providing initial support, and escalating complex issues. Required Candidate profile BE/Btech/Diploma Tecdhnical Background mandatory

Role & responsibilities Demonstrated experience in authoring and review of Module 3 CMC sections for post-approval CMC variations, renewals, annual reports, legal entity name change variations and other lifecycle maintenance activities, according to current government regulations and guidelines Strong experience in assessing the change control issued by quality or regulatory department. Assess the regulatory impact of the change and develop submission strategy. Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions. Contribute to or prepare administrative...