354 Dmf Jobs - Page 8

Responsible for producing and presenting food items to meet customer and client expectations and Sodexo India standards as well as maintain and continuously improve the efficiency and profitability of the operation. Ensure that safety and hygiene policy is strictly followed at the site Control the quantity and quality of the ingredients and ensure that all items are received as per the laid down specifications; responsible for training the receiving area staff on ingredient quality Responsible for maintaining record of all hygiene related procedures, initiatives and incidents Responsible for co-ordination with the QMHSE and H&FS teams to implement the policy and process Ensure that all incid...

Modification and Projects Involved in new project activitiesInvolved in modification activitiesSupport to Instrumentation team for project activities pre requisite Daily Operations Preventive Maintenance of autoclaves, fermenters, TFF systems, process vessels, blast freezers, CIP vessels, homogenizers, mixers, CIP trolleys, LAFUs, BSC, Cold rooms, Refrigerators etc General Notifications and breakdown notification closures3 General notification planned for closure relate to new requirement Breakdown activities critical (W/o notifications) Related to autoclave door issue, agitator seal related issue, breakdown of equipment Project activities/new initiative/continuous improvement/safety related...

Modification and ProjectsInvolved in new project activitiesInvolved in modification activitiesSupport to Instrumentation team for project activities pre requisite Daily Operations Preventive Maintenance of autoclaves, fermenters, TFF systems, process vessels, blast freezers, CIP vessels, homogenizers, mixers, CIP trolleys, LAFUs, BSC, Cold rooms, Refrigerators etc General Notifications and breakdown notification closures3 General notification planned for closure relate to new requirement Breakdown activities critical (W/o notifications) Related to autoclave door issue, agitator seal related issue, breakdown of equipment Project activities/new initiative/continuous improvement/safety related ...

WTP OPERATORFollow daily shift activates without deviations. Follow daily operations and logbooks updation as per SOP. Please coordinate with MAC and calibration activity with internal team. WTP snatization activates as per schedule

Responsible for preparing, producing and presenting food as per Sodexo India standards and within budget in accordance with company policy Key Responsibilities Prepare, cook and produce food to the companies standard, with particular emphasis on presentation, hygiene and economy Ensure proper cleanliness of the kitchen equipment and flooring Observe all safety rules and procedures Ensure that equipment and materials are not left in dangerous state Ensure proper grooming and hygiene for self and for all staff under him Assist Manager / Site In-charge / Sous chef / Sr cook in indenting for provisions In addition, any other assignment given occasionally or on a daily basis by the immediate supe...

Sodexo Food Solutions India Pvt. Ltd. is looking for Assistant - F&B to join our dynamic team and embark on a rewarding career journey As an FB Associate, you will be responsible for ensuring exceptional customer service, maintaining cleanliness and hygiene standards, and assisting in various aspects of food and beverage operations Responsibilities: Customer Service:Greet customers warmly and assist them in selecting menu items Take food and beverage orders accurately and efficiently Provide recommendations and answer customer inquiries about menu items Ensure customer satisfaction by addressing any concerns or complaints promptly and professionally Food and Beverage Preparation:Prepare and ...

Responsible for preparing, producing and presenting food as per Sodexo India standards and within budget in accordance with company policy Key Responsibilities Prepare, cook and produce food to the companies standard, with particular emphasis on presentation, hygiene and economy Ensure proper cleanliness of the kitchen equipment and flooring Observe all safety rules and procedures Ensure that equipment and materials are not left in dangerous state Ensure proper grooming and hygiene for self and for all staff under him Assist Manager / Site In-charge / Sous chef / Sr cook in indenting for provisions In addition, any other assignment given occasionally or on a daily basis by the immediate supe...

Follow daily shift activates without deviations Follow daily operations and logbooks updation as per SOP Please coordinate with MAC and calibration activity with internal team WTP snatization activates as per schedule

Responsibilities: Assist in the preparation and compilation of regulatory dossiers (CTD / ACTD / eCTD) for product registration in various markets. Support the collection and review of technical documents from R&D, QA, QC, and Production departments. Help maintain regulatory databases, tracking sheets , and product registration status logs. Learn and follow current regulatory guidelines (USFDA, WHO, MHRA, EU, CDSCO) . Assist in the submission of post-approval changes , annual updates, and renewal applications. Draft and format regulatory documents, letters, and summaries . Help respond to regulatory agency queries and deficiencies under guidance. Ensure compliance with documentation practice...

Responsibilities: Dossier Preparation & Submission Prepare, compile, and review CTD / ACTD / eCTD dossiers for product registration in global markets. Coordinate for ANDA, DMF, CEP, COS, and other regulatory submissions for APIs and formulations. Ensure accuracy and completeness of Module 15 in line with specific regulatory authority requirements. Regulatory Compliance & Communication Ensure continuous regulatory compliance of products as per cGMP and ICH guidelines. Review and submit annual reports, amendments, variations, and renewals as required. Communicate with regulatory agencies and address queries, deficiencies, and clarifications (Q&A) in a timely manner. Documentation & Data Collec...

Job Description Position Summary We are seeking a Senior Officer- Regulatory affairs (US Markets ) to join our team, he will be reporting to Deputy General Manager in this role, you will be responsible for Dossier compilation, preparation, Life cycle management, Pre approval, Post approval Key Responsibilities: Collate/prepare and file dossiers in a timely and accurate manner for formulations/ drug products to get licenses from targeted markets. Prepare the checklist for documentation for regulatory filings as per current regulatory requirements (country specific). Collate and conduct review/overview of relevant standard technical documentation like stability, TTD, PDR, method validations, E...

As a Dynamics AX X++ Developer at the company, you will be responsible for the following: - Demonstrating strong coding skills in Dynamics AX X++ and related technologies/tools such as DMF, SSRS, SSAS, Workflow, Batch framework, and Security framework. - Reviewing and understanding functional designs of business requirements to prepare detailed technical designs. - Producing high-quality Technical Design Document (TDD) in adherence to set standards and templates. - Collaborating with technical teams on GAP requirements to maintain consistent technical quality. - Engaging in discussions with functional consultants for design clarifications. - Assisting other development teams to ensure projec...

What you will do 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 Management, Monitoring, and Engagement...

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 for maintaining U.S. state and federal com...

ABOUT THE ROLE The Regulatory Affairs Senior Associate role assists US Promotion Regulatory representatives and other cross-functional roles in the administration of regulatory strategies for department initiatives across all product brands. This role assists with preparing, tracking, reporting, and archiving US regulatory documentation, including preclearance and advisory comment promotional materials, and is responsible for all Ad/Promo regulated data management. This role performs the planning and tracking of all US promotional label changes and manages the system update of promotional labeling and Important Safety Information (ISI). This role is responsible for US digital labeling and tr...

ABOUT AMGEN Roles & Responsibilities: Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, or prepare documents for public registries e.g. ClinicalTrials.gov Work closely with cross functional stakeholders to define redaction strategy and disclosure, lead review and approval, ensure submission readiness, and hand off for timely submission or posting Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting Communicate with team members or cross-functional stakeholders to resolve problems and escalate issues Record and maintain w...

The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company's products meet and maintain regulatory standards. They assist in preparing submissions for regulatory agencies, keep updated on changes in regulatory legislation, and guide various teams within the company to ensure compliance with applicable regulations. 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...

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 ...

Role Description: The International Regulatory Lead (IRL) Sr Associate will provide coordination and execution of regulatory deliverables for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to optimize product development and regulatory approvals in International countries develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities: With support, advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives. Lia...

Roles and Responsibilities Review documents from various departments to compile regulatory submission. Oversee drug master file for submission to regulatory authorities, including updates, amendments, and revisions as required. Draft both the applicant and restricted parts of DMF s to ensure regulatory complience. Coordinate with CFT to address deficiency and feedback from RA and customers. Conduct CFT meetings to ensure timely responses to regulatory deficencies and customer inquires. Provide regulatory guidance to product development teams and attend technology transfer meetings to support compliance. Respond promptly to technical queries from regulatory bodies and customers.

Role Name: Manager International Regulatory Lead (IRL) Department Name: International Regulatory Team, Global Regulatory Affairs Role GCF: 5A ABOUT THE ROLE Role Description The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to -optimize product development and regulatory approvals in International countries -develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities -Advises Global teams on regulatory impl...

Job Summary: Amgen is seeking a Manager, Regulatory Affairs CMC Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a meaningful impact on regulatory efficiency and compliance. Join us in revolutionizing regulatory submissions through cutting-edge data automation! Key Responsibilities: Support the implementation of automation and digital tools to streamline regulatory CMC documentation and submission workflows. Assist in developing standardized templates a...

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. Amgens CMC submission execution team, R egulatory O ptimization o f T actical and S trategic S upport (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC and/or Device submission execution for Amgen products across phases of development, modality and countries. The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC t...

Regulatory Affairs Associate Responsible for preparation, review & submission of regulatory documents (US FDA, EMA, ICH), ensuring compliance with guidelines, supporting product approvals, maintaining records & coordinating with authorities. Required Candidate profile BSC/MSC/B.Pharm or Life Sciences graduate with knowledge of regulatory guidelines, dossier prep, submission processes, documentation, compliance, MS Office, attention to detail & communication skills.

Role & responsibilities Prepare CTD dossiers for regulated markets and other markets as per country specific guidelines. Attend to various queries raised by the importing countries wrt to Co.products & dossiers. Coordinate with factory.Role & responsibilities Preferred candidate profile 1-3 Years Experience In Regulatory Affairs for formulations. Excellent communication skills both written and verbal.