299 Cmc Jobs - Page 7

Skills: "Industrial Hydraulics", "Hydraulic Power Pack", "Hydraulic Circuit", "Mobile Hydraulics" "Pneumatics", Yuken, Hydac, Parker, Veljan, Danfoss, Eaton, Atos, Bucher, (Employed in Direct Brand or their Dealer), Hydraulic PumpsHydraulic MotorsTorque HubsValvesManifoldsPower UnitsCylindersAccumulatorsJoysticksFoot PedalsSpare Parts, Experience in Service sales, Concept of AMC & CMC Contracts, Analytical and conceptual capabilities, Experience in AUTOCAD, MS word/ EXCEL; Presentation skills,. Industry:Engineering. Location and no. of position:. Kolkata (areaWB)01. Guwahati (areaNorth East)01. Benefits:PF, Cashless Medical Insurance at all top Hospitals for Full Family. Qualification:Diplom...

Primary Responsibilities: Responsible for finalizing the CMC regulatory strategies for assigned products and provide support to execute tasks independently in accordance with global regulations and guidance procedures. Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle. Execute regulatory strategies by leading the development, Review and approval of CMC submission components and documentation to support post-approval supplements, and responses to health authority questions per established business processes and systems. Lead the Change control evaluation, preparation, and sub...

Responsibilities: Manage service sales team & customer relationships Oversee warranty management & spares supply chain Ensure contract compliance & renewals Develop after-sales strategies & marketing plans Food allowance Health insurance Annual bonus Provident fund

":"Phd/ Doctorate, M.Sc. " , "process_Name":"R&D" , "vacancyKeyskills":" Ensure accurate analysis of samples in time Ensure that laboratory work is carried out in a safe manner. Ensure that equipment are in working condition all the time. Ensure that analytical division complies with relevant statutes. Ensure that knowledge generated is captured in an easily retrievable form. Ensure compliance of systems implemented. Ensure timely completion of Projects. ","vacancyKeyroles":" Execution of analytical plan for the assigned projects. Interpretation of analytical results and prepare analytical reports. Record and report the observations during analysis. Documentation of analytical work. Interact...

1. Warehouse Operations a. Ready to come in all shift timings b. Maintaining Receiving to Binning Ratio as per target c. Defining Storage and Picking Strategies d. Picking operations as per Customer orders e. Perpetual / Annual Inventory, Variance reporting & countermeasures to reduce variances f. Customers (Domestic / Exports) dispatches and quality delivery g. Maintaining Order to Dispatch Ratio h. Ensuring Safety, 5S, MHE Procurement & Maintenance in Warehouse i. Necessary approvals to run business (Purchasing of MHE, Service - AMC / CMC) j. Spare Parts Vehicle Unloading (Unloading TAT Monitoring) k. Maintaining Export Discrepencies at 0 level 1. Soft Skills - Inter-personal skills - Co-o...

Position Title: Digital Product Owner Chemistry, Manufacturing and Controls (CMC) About Chemistry, Manufacturing and Controls CMC refers to the methods and tests used to ensure that a pharmaceutical product meets the required quality standards before it is approved for market use. It encompasses various aspects of drug development, including formulation, manufacturing processes, and quality control. About the Job We are looking for a Digital Product Owner to lead the development of innovative data products supporting Chemical, Manufacturing and Control operations. This role will work closely with the Product Owner CMC, focusing on enabling data-driven decision-making in CMC operations using ...

Incoda Media is looking for Assistance Manager / Manager - Media Sales 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 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 a...

Job Title: Intern CMC (Formulation) Duration: 12 Months (1 year) Location: Hyderabad Department: CMC (Formulation) Reporting To: Lead Scientist - CMC (Formulation) Stipend: Paid Qualifications: Master s degree in Pharmaceutical Sciences (Pharmaceutics) or related discipline from a reputed institution. Strong academic background in pharmaceutics Basic knowledge of formulation principles and analytical techniques. Familiarity with regulatory guidelines (e.g., ICH, FDA, EMA) is an advantage. Proficient in MS Office (Word, Excel, PowerPoint) and scientific writing. Excellent communication, organizational, and problem-solving skills. Position Summary: The Formulation R&D Intern will support the d...

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 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 health...

The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketin...

Career Category Regulatory Job Description Let s do this. Let s change the world. In this vital role you will report into the Regulatory Compliance Team lead. The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain for specific strategies or activities that impact a product. The Change Assessor will be responsible for varying levels of product support, including global reportability assessment of single or cross-product changes, based upon their experience level. Roles & Responsibilities: Key responsibilities of the Regulatory Manager include: Reviews change record...

Career Category Regulatory Job Description The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain for specific strategies or activities that impact a product. The Change Assessor will be responsible for varying levels of product support, including global reportability assessment of single or cross-product changes, based upon their experience level. Roles & Responsibilities: Key responsibilities of the Regulatory Sr Associate include: Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in sc...

Role & responsibilities Handling of pre and post approval regulatory activities of US/EU/CA submissions. Review of developmental documents for regulatory submission. Good knowledge of handling CMC documentation for Dossier submission Compilation and Submission of Annual reports and Supplements. Having the experience of solid orals and injectables. Preparation of Sterility Assurance Package for injectable Dossiers. Preparation of Pre-IND/scientific advice meeting packages Drafting, compiling & eCTD publishing of dossiers for regulatory filings. Review of specifications and test procedure as per pharmacopoeia requirements. Providing regulatory support for customer filings and customer queries....

Roles and Responsibilities Prepare ANDA dossiers, CMC modules, and submission documents for US FDA approval. Post approval and life cycle management of approved ANDA & suppliment filling. Review and prepare labeling documents (labels, cartons, pack insert) according to US regulations. Develop expertise in various therapeutic areas such as Cardiology, Diabetology, Neurology, Ophthalmology etc. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Ensure timely submission of applications to USFDA while maintaining high-quality standards. Desired Candidate Profile 8-10 years of experience in Regulatory Affairs with a focus on US market. Bachelor's degree in ...

- 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 of th...

Profile: Medical Lab Incharge Onsite and Permanent Job description: Roles and Responsibilities: - Authorize release of test report based on the Buyers protocol & test methods - On time responds to Buyers & clients queries, emails and calls - Responsible for reviewing revisions, updates on test parameters, protocols and regulations, etc. and circulating these to the concerned lab team - Training lab staff as per updated, revised protocol received from clients and brands - Support team to develop capability on new test parameters as received in buyer protocol - Training & Supervising the handling, operating and maintenance of test equipment. - Supervising preparation and maintenance of documen...

Profile: Medical Lab Incharge Onsite and Permanent Job description: Roles and Responsibilities: - Authorize release of test report based on the Buyers protocol & test methods - On time responds to Buyers & clients queries, emails and calls - Responsible for reviewing revisions, updates on test parameters, protocols and regulations, etc. and circulating these to the concerned lab team - Training lab staff as per updated, revised protocol received from clients and brands - Support team to develop capability on new test parameters as received in buyer protocol - Training & Supervising the handling, operating and maintenance of test equipment. - Supervising preparation and maintenance of documen...

As the Regulatory Manager (CMC, EU & Japan/China) at Syneos Health, you will be part of a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. Our focus is on translating clinical, medical affairs, and commercial insights into tangible outcomes that address the realities of the modern market. In our Clinical Development model, we prioritize placing the customer and the patient at the center of all our activities. We strive to simplify and streamline our processes, not only to enhance our interactions with clients but also to create a more conducive working environment for our employees. Whether you are engaged in a Functional Service P...

This is a full-time on-site role for a Manager / Deputy Manager Regulatory Affairs located in Vadodara. As the Manager / Deputy Manager, your responsibilities will include developing and implementing regulatory strategies, ensuring compliance with regulatory requirements, preparing and submitting regulatory documents, and maintaining regulatory files. Your role will involve interacting with regulatory agencies, managing timelines, and ensuring that all products meet regulatory standards. Your key responsibilities will be to develop and direct global regulatory strategies for clinical, non-clinical, and CMC aspects. You will lead the preparation, review, and approval of submission documents f...

Summary -Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HAs on REG CMC questions to support new product or post marketed launches. About the Role Major accountabilities: Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance -Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Identify the required documentation and...

Eurofins Scientific through its subsidiaries is a world leader in food, environment, pharmaceutical and cosmetic product testing, discovery pharmacology, forensics, advanced material sciences, and in agroscience Contract Research services. It is also one of the global independent market leaders in genomics and in the support of clinical studies, as well as in BioPharma Contract Development and Manufacturing. In addition, Eurofins is one of the key emerging players in specialty esoteric and molecular clinical diagnostic testing in Europe and the USA. With ca. 62,000 staff across a network of over 1,000 independent companies in 62 countries and operating over 900 laboratories, Eurofins offers ...

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inc...

Lead QA oversight for RD, analytical process development, and tech transfer. Ensure compliance with GMP, GLP, ICH, and global regulatory standards. Review and approve development protocols, validation reports, and CMC docs. Handle deviations, CAPAs, change controls, and data integrity (ALCOA+). Support audits, inspections, and regulatory filings (IND, BLA, DMF). Mentor and manage QA team, and drive quality culture across development.

Oversee and manage the preparation, submission, and tracking of regulatory dossiers for product registrations, renewals, and variations across Asia , including but not limited to ASEAN, South Asia, East Asia, and Middle East regions. Conduct thorough regulatory reviews of dossier sections (Quality) to ensure alignment with country-specific requirements and ICH guidelines . Coordinate with internal teams RA(CMC), QA, Manufacturing, Clinical Affairs, Local (country specific) and external stakeholders to ensure timely and accurate submissions . Manage regulatory responses to queries and deficiency letters from health authorities and clients , ensuring resolution within timelines. Assess the reg...