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5.0 years

0 Lacs

Hyderabad, Telangana, India

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Summary The Purpose of the Specialist role is having expertise in Extractables and Leachables assessment, work in close collaboration with multiple functions such as MS&T, Supplier management, Regulatory, Toxicology, Procurement, Quality and Production. The individual plays a key role in support of Extractable and Leachable activities with a strong focus on data collection, Risk rating, assessments and evaluation. About The Role Location – Hyderabad Key Responsibilities Extractable and Leachable (E&L) Expertise Understanding of Extractable and Leachable (E&L) risk assessment for materials based on supplier information and the ability to determine the risk level and update the Risk assessment. Building a comprehensive material library backed by corresponding E&L test data Managing the coordination for Extractables studies or product-specific leachable studies. Preparation of E&L Risk assessment, E&L testing Protocol and Report. Compile E&L data and provide the information to Toxicologist for assessment. Proficient in risk evaluation, decision matrix, Gap Analysis, and outcome understanding manufacturing materials. Comprehensive knowledge of the chemical and physical properties (leaching tendency) of MOC materials Skilled in defining the Original risk level, Mitigation factor, and Final risk level as part of the Risk Assessment process. Expertise in Extractable studies, their methodologies, analytical strategies, and design Expertise in setting the AET (Analytical Evaluation Threshold) and SCT (Safety concern threshold) for extractables and leachables detected during testing. Detailed understanding of E&L guidelines (SOPs, Pharmacopoeia and ICH standards) Proficient in identifying and assessing the Worst-case material representative approach. Collect the material list and data information from development centers and manufacturing sites. Active participation in E&L taskforce and network meetings. Also responsible for coordinating with the development, Supply management, QC, and Production department. Commitment to Diversity & Inclusion: : We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Essential Requirements Preparation of process and cleaning validation documentation (Protocols, reports) as well as change evaluations for new product launches and Life cycle management activities. Ensure project tracking documentation/tools are updated according to plan Collaborate closely with the development organization (or sending site) for technical transfers and new product launches to ensure knowledge transfer, appropriate control strategies, risk analysis and control, and readiness for commercial process validation Ensure that data integrity checks are conducted to verify that all the data is complete, consistent, and free from errors before proceeding with any further analysis or reporting Coordination of documentation review with the site MS&T, QA, and QC, also Reg CMC where applicable Preparation, approval and life cycle management of Gxp documents Training Own the Training Curriculum for Own Job Profile Desirable Requirements Bachelor's degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biotechnology, Chemistry, or equivalent science streams. Desirable MSc/MS. or equivalent experience. Min 5 years of experience in MS&T or in the manufacturing of pharmaceutical Drug substance and Product for Small and Large molecules. Should be familiar with regulatory guidance on ICH Q3,Validation, Product filing and Post approval changes. Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions). Expertise in reviewing and writing technical reports Good communication, Presentation and Interpersonal skills. Proficiency in English (oral and written) is required. Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

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Vadodara, Gujarat, India

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Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Exe/ Senior Executive Date: May 21, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Histopathology evaluation and report preparation of pharmacology studies Planning, designing and monitoring of GLP/Non -GLP toxicity studies in rodent and non-rodent Scientific data collection, interpretation of toxicology data and study report preparation/review. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

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10.0 years

0 Lacs

Mumbai Metropolitan Region

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Job Title: Lead Expert Regulatory Affairs – TTH, ISOL , ISC Location : Mumbai JobType: Hybrid In this role our ideal candidate will serve as a regulatory support for DSM Firmenich’s Taste Texture and Health (TTH) , ISOLs BU for Indian Subcontinent team ingredient technologies. Will deliver exceptional customer service on projects, programs and/or processes to ensure regulatory compliance. At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work, benefiting to our People, Customers & Communities and driving business value. Equal access to opportunities is a given, belonging is a shared feeling, authenticity is celebrated. Your Key Responsibilities Accountable for regulatory compliance support of Ingredient solution products business in Indian subcontinent Provide customers and business partners with answers to product claims, labelling and compliance-related questions as well as creative compliance options. Collaborate with internal stakeholders in finding regulatory solutions for Ingredient Solution topics. Identify opportunities to leverage regulatory as a strategic partner for DSM-Firmenich Drive efficiencies and look to continuously improve upon ways of working and best in class delivery of services to our customers. Keep up to date with latest industry regulations that directly impact the TTH portfolio. Responsible for providing customer compliance documentation We bring The opportunity to work for a company where sustainability is much more than a claim and is core to our strategy and purpose; A flexible work environment that empowers people to take accountability for their work and own the outcome; Barrier-free communities within our organization where every employee is equally valued and respected – regardless of their background, beliefs, or identity; A firm belief that working together with our customers is the key to achieving great things; An eagerness to be one team and learn from each other to bring progress to life and create a better future We offer competitive pay, career growth opportunities, and outstanding benefit programs You bring Minimum of a bachelor’s degree in Food Science or closely related science discipline (Nutrition, Chemistry, Toxicology, Nutraceutical, Pharmacy,Biotechnology ) with a minimum of 10 years food regulatory experience, Indian Subcontinent food and Nutrition regulations experience. Strong collaboration skills Able to work in a fast paced and agile environment. High attention to detail and strong critical thinking skills Strong written and verbal communication skills Strong computer software skills (excel, word, SAP, etc.) The application process. Interested in this position? Please apply on-line by uploading your resume in English via our career portal. For further information. Equal Opportunities Commitment dsm-firmenich is fully dedicated to inclusion because when people feel engaged and empowered, their creativity and innovation drives unprecedented progress. We aim to build a workplace where opportunity really is equal, so everyone can thrive. We do not discriminate; there's a place for everyone at dsm-firmenich. Dsm-firmenich is an Equal Opportunity and Affirmative Action Employer. dsm-firmenich people are as diverse as our customers. For us that includes a commitment to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law. We are committed to providing reasonable support for disabled applicants in our recruiting process. Should you need assistance, and are comfortable to share this, please let us know. About Dsm-firmenich As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world's growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create what is essential for life, desirable for consumers, and more sustainable for the planet dsm-firmenich is a Swiss Dutch company, listed on the Euronext Amsterdam, with operations in almost 60 countries and revenues of more than €12 billion. With a diverse, worldwide team of nearly 30,000 employees, we bring progress to life™ every day, everywhere, for billions of people Show more Show less

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2.0 - 7.0 years

1 - 5 Lacs

Mumbai, Mumbai Suburban

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- Assist in Dossier preparation and review various reports. - Coordinate with various institutes and Overseas experts on Toxicology, Efate and physiochemical part of dossiers - liaison, negotiate with labs and timely completion of studies -Chemicals Required Candidate profile Graduate or Post Graduate in Chemistry, Agriculture or Bioscience. Excellent in oral and written communication. Ability to manage complex issues and prioritize workload.

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10.0 years

0 Lacs

Kurla, Maharashtra, India

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Ashland India Private Ltd Are you the kind of person that is always thinking, sketching, seeking, and adjusting? Who needs to understand how things work and then figure out how they can work better? Are you a passionate, tenacious, solver who loves to work with others who share your drive? Are you positive, constructive, and ingenious? Are you always solving? Then we’d like to meet you and bet you’d like to meet us. Ashland has an exciting opportunity for a Hazard Communication Lead to join our team at our Mumbai IN location. This is a very visible, significant role within the Company and the Regulatory Affairs function. This position will report to the Manager, Regulatory Affairs. The responsibilities of the position include, but are not limited to, the following: Expert knowledge of and ability to apply classification to chemical components according to country specific GHS regulations for all physical, environmental and health hazards. Apply classifications of Dangerous Goods according to the UN Orange Book guidelines Experience in conducting research of available toxicological characteristics using online databases and other sources of information. Ability to evaluate the toxicological data to determine relevancy and quality. Evaluate hazard communication regulations and the related SAP EHS expert rule logics. To identify and lead management of change processes based on changing component and product classification and change in raw material composition. To identify and help to streamline processes resulting in higher efficiency and increased output. Be able to lead process improvement initiatives. Maintain awareness of new product/chemical safety legislation and changes to regulations impacting products and businesses. Provide training to new team members, regulatory colleagues, and business partners on issues, requirements, and processes. Experience of authoring and reviewing GHS compliant SDS’s including eSDS’s and labels. Experience of implementing ACC’s product safety code, doing risk prioritization, risk characterization and determining risk management measures. In order to be qualified for this role, you must possess the following: Doctorate/Masters/Bachelors degree in Toxicology, Pharmacology, Biochemistry or other relevant scientific field. 10+ years’ experience in GHS hazard classification of components and mixtures. Experience in conducting toxicology/ecotoxicology hazard assessments. Expert knowledge of global hazard communication regulations (GHS, CLP, OSHA HazCom, etc). Knowledge of related regulations. (TSCA, REACH, Prop 65, etc.). The Following Skill Sets Are Preferred Technical knowledge – toxicology, ecotoxicology, and general/ organic chemistry (in context of Hazard Classification), as well as Hazard Communication, Global Regulations, and Dangerous Goods classification SDS authoring certification Attention to detail Service oriented and sensitive to business needs without losing focus of legislative requirements Good analytical and problem-solving skills Be willing to be innovative and function effectively as a team player. Results oriented and self-motivating Bias for action, capability to define, evaluate and take risks Strong interpersonal skills Excellent communication skills both written and oral (in English) Strong intellectual curiosity appetite for exploring new and previously uncharted territories Openness to change and ability to think out of the box Excellent presentation skills In more than 100 countries, the people of Ashland LLC. (NYSE: ASH) provide the specialty chemicals, technologies and insights to help customers create new and improved products for today and sustainable solutions for tomorrow. Our chemistry is at work every day in a wide variety of markets and applications, including architectural coatings, automotive, construction, energy, personal care and pharmaceutical. Visit www.ashland.com to see the innovations we offer. At Ashland our vision is to be a leading, global specialty chemicals company whose inspired and engaged employees add value to all we touch. In fact our people, employees, customers and vendors define who we are. They are the driving force behind everything we do. Not only do we value our customers but we value our employees, and we work to offer them a dynamic and challenging environment. We hold ourselves to high standards at Ashland, and we value integrity and honesty. Ashland has a history of attracting the best people and keeping them. The reasons are simple: industry competitive salary and benefits, pay-for-performance incentive plans and a diverse work environment where employees feel challenged and valued. People come to Ashland and stay. As a growing Fortune 500 specialty chemicals company, we offer opportunities for development and advancement throughout our global organization. Our values define who we are and what we care about as a company. If you are looking for a relationship with a company instead of simply a job, this may be a great fit. Ashland is proud to be an Equal Opportunity Employer Minorities/Women/Veterans/Disabled/Gender Identity/Sexual Orientation. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, or protected veteran status and will not be discriminated against on the basis of disability. NOTE: We do not accept resumes from external staffing agencies or independent recruiters for any of our openings unless we have a signed recruiting agreement in place to fill a specific position. Show more Show less

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Vadodara, Gujarat, India

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Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Senior Executive Date: May 21, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Histopathology evaluation and report preparation of pharmacology studies Planning, designing and monitoring of GLP/Non -GLP toxicity studies in rodent and non-rodent Scientific data collection, interpretation of toxicology data and study report preparation/review. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

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4.0 years

0 Lacs

Hyderabad, Telangana, India

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Company Name: Vivo Biotech Limited About our company Vivo Bio Tech Limited is a leading preclinical Contract Research Organization (CRO) based in Hyderabad, India. Vivo is OECD-GLP accredited, AAALACi certified pre-clinical testing facility. We specialize in offering comprehensive preclinical safety and analytical services across a wide range of industries, including pharmaceuticals, agrochemicals, industrial chemicals, medical devices, biopharmaceuticals, vaccines, herbal/nutraceuticals, and cosmetics. Position: Study Director - Toxicology Experience: 4+ years Location: Pregnapur, Hyderabad Job Description: 1. To act as a single point of control for conducting toxicity and efficacy studies (In-vivo and In-vitro) studies. 2. Responsibility for overall scientific conduct of the studies in compliance with the Principles of GLP, regulatory test guidelines and animal welfare guidelines like CCSEA. 3. Experience in conducting Acute, Repeated Dose, Reproductive, Inhalation, Immunogenicity and Neurotoxicity studies. 4. Hands on experience with various product lines like Pharma, Agrochemical, Industrial Chemicals, Microbial pesticides, Medical device, Biosimilars, Vaccines etc., 5. Experience in dosing different routes of administration in small & large animal models. 6. Functions will include study plan (and amendment) design and approval in accordance with internal procedures and where appropriate, in compliance with international regulations. 7. Effective co-ordination with cross functional team for proper planning, designing of the experiment, execution and reporting of the results. 8. Interpretation of the results, writing the discussion and conclusion for the final report. 9. To conduct and participate in the functional and cross functional meeting with respect to studies planned, ongoing or completed. 10. Familiar with the regulatory test guidelines (eg., OECD, ICH, ISO) and GLP Principles. 11. Knowledge in statistical analysis. 12. Liaise with the sponsor, auditors and consultants on study related materials. 13. Effective co-ordination with Quality Assurance & Management. 14. Sound communication with managerial skill. 15. Having proficiency in the various applications such as MS Word, Excel, PowerPoint etc., Thanks & Regards G NagaSravani - HR nagasravani.g@virinchi.com Show more Show less

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0.0 - 1.0 years

0 Lacs

Noida

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" JOB DESCRIPTION Jubilant Bhartia Group Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S Bhartia and Mr. Hari S Bhartia with strong presence in diverse sectors like Pharmaceuticals, Contract Research and Development Services, Proprietary Novel Drugs, Life Science Ingredients, Agri Products, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Jubilant Bhartia Group has four flagships Companies- Jubilant Pharmova Limited, Jubilant Ingrevia Limited, Jubilant FoodWorks Limited and Jubilant Industries Limited. Currently the group has a global workforce of around 43,000 employees. About Jubilant Biosys Jubilant Biosys Ltd is a part of the Jubilant Pharmova family of companies with R&D centres in India and business offices in Asia and North America. With our global reach, Jubilant Biosys provides comprehensive drug discovery services and contract research services from target discovery to candidate selection and with flexible business models (FFS, FTE and risk shared) in partnership with leading worldwide healthcare companies. With a clear scientific focus in oncology, metabolic disorders, central nervous system (CNS) diseases, pain and inflammation, Jubilant Biosys has rapidly emerged as a leading collaborator for pharmaceutical and biotechnology companies worldwide. In each of these therapeutic areas, Jubilant Biosys has developed a deep level of expertise in discovery informatics, computational chemistry , medicinal chemistry, structural biology , biology, in-vivo , in-vitro models and translational sciences. Combined with strong clinical development and manufacturing capabilities from other Jubilant subsidiaries, Jubilant Biosys has risen as a fully integrated contract research organization in India and headquartered at Bengaluru with end-to-end solutions. Our ability to be the preferred collaborator in the drug discovery domain is sustained by our commitment to comply with and continually improve our quality systems and to provide the following services: Contract Research Preclinical CRO Drug Discovery Virtual Screening Protein Crystallization Toxicology & In-vitro ADME Medicinal Chemistry Synthetic & Developmental Chemistry Pharmacology Jubilant Biosys collaborates with the world s leading pharmaceutical, biotech companies, academic institutions and research foundations. Find out more about us at www.jubilantbiosys.com The Position Organization : - Jubilant Biosys Designation & Level: - Trainee research Associate/ A0 Location : - Greater Noida Department: - Synthesis Reporting Manager: - Group Leader Key Responsibilities Synthesis, purification and characterization of chemical intermediates. Deliver small to large quantities of novel chemical entities for drug discovery. Work collaboratively in a team to drive chemistry projects forward. Excellent knowledge of basic organic chemistry with mechanism. Good knowledge of Name Reactions & functional group transformation. Good knowledge of molarity, normality, equivalency. Practical experience in thin-layer chromatography, column purification and extraction. Good understanding of NMR, IR and mass spectrometry. Interest to adapt and knowledge of laboratory safety practices. Enthusiasm to work in a dynamic research environment. Good Soft & Scientific Communication skills. Person Profile Qualification: - M.Sc. in Chemistry/Organic Chemistry/Pharmaceutical Chemistry or related field or M. Pharma (Specialized in Organic Synthesis) with 0-1 years project experience. Experience: - 0-1 year of exp. Jubilant is an equal opportunity employer. . ",

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6.0 - 10.0 years

6 - 13 Lacs

Hyderabad

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Role & responsibilities Support Preclinical Development Strategy Assist in devising and implementing preclinical development strategies for new drugs or generics, including literature review and assimilation of relevant scientific data. Contribute to the design and planning of in vivo and in vitro studies, ensuring alignment with regulatory and therapeutic goals. Study Management and Oversight: Coordinate and support the execution of pharmacodynamics, pharmacokinetics, and toxicological studies, often at contract research organizations (CROs). Verify test article characterization data and review preclinical study protocols, data, and reports for accuracy and compliance. Ensure timely execution of studies in collaboration with CROs and internal teams, maintaining data integrity and regulatory compliance. Data Analysis and Interpretation Compile, analyze, and interpret preclinical data, including statistical analysis of biological results. Prepare study findings for internal discussions, decision-making, and regulatory submissions. Present results in team meetings and contribute to technical reports, study summaries, and presentations. Regulatory Support Review and prepare documentation for regulatory submissions (e.g., IND, NDA, BLA), ensuring all preclinical data meet regulatory requirements. Address and resolve regulatory queries related to pharmacokinetics, efficacy, or toxicity by providing scientific justifications and literature support. CRO and Vendor Management Participate in the identification, selection, and management of CROs for preclinical studies. Set up contracts, handle shipments, and oversee administrative tasks related to external service providers. Cross-functional Collaboration Collaborate with internal and external stakeholders, including discovery research, clinical pharmacology, and regulatory affairs, to ensure seamless project progression. Contribute to the overall translational research strategy and integrate preclinical insights into broader project decisions. Documentation and Compliance Ensure that all work is conducted in a safe, ethical, and compliant manner, adhering to Good Laboratory Practice (GLP) and other relevant standards Preferred candidate profile Perks and benefits

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0.0 - 1.0 years

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Sadar, Uttar Pradesh, India

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Job Description Jubilant Bhartia Group Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S Bhartia and Mr. Hari S Bhartia with strong presence in diverse sectors like Pharmaceuticals, Contract Research and Development Services, Proprietary Novel Drugs, Life Science Ingredients, Agri Products, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Jubilant Bhartia Group has four flagships Companies- Jubilant Pharmova Limited, Jubilant Ingrevia Limited, Jubilant FoodWorks Limited and Jubilant Industries Limited. Currently the group has a global workforce of around 43,000 employees. About Jubilant Biosys Jubilant Biosys Ltd is a part of the Jubilant Pharmova family of companies with R&D centres in India and business offices in Asia and North America. With our global reach, Jubilant Biosys provides comprehensive drug discovery services and contract research services–from target discovery to candidate selection and with flexible business models (FFS, FTE and risk shared)–in partnership with leading worldwide healthcare companies. With a clear scientific focus in oncology, metabolic disorders, central nervous system (CNS) diseases, pain and inflammation, Jubilant Biosys has rapidly emerged as a leading collaborator for pharmaceutical and biotechnology companies worldwide. In each of these therapeutic areas, Jubilant Biosys has developed a deep level of expertise in discovery informatics, computational chemistry , medicinal chemistry, structural biology , biology, in-vivo , in-vitro models and translational sciences. Combined with strong clinical development and manufacturing capabilities from other Jubilant subsidiaries, Jubilant Biosys has risen as a fully integrated contract research organization in India and headquartered at Bengaluru with end-to-end solutions. Our ability to be the preferred collaborator in the drug discovery domain is sustained by our commitment to comply with and continually improve our quality systems and to provide the following services: Contract Research Preclinical CRO Drug Discovery Virtual Screening Protein Crystallization Toxicology &In-vitroADME Medicinal Chemistry Synthetic & Developmental Chemistry Pharmacology Jubilant Biosys collaborates with the world’s leading pharmaceutical, biotech companies, academic institutions and research foundations. Find out more about us at www.jubilantbiosys.com The Position Organization : - Jubilant Biosys Designation & Level: - Trainee research Associate/ A0 Location : - Greater Noida Department: - Synthesis Reporting Manager: - Group Leader Key Responsibilities Synthesis, purification and characterization of chemical intermediates. Deliver small to large quantities of novel chemical entities for drug discovery. Work collaboratively in a team to drive chemistry projects forward. Excellent knowledge of basic organic chemistry with mechanism. Good knowledge of Name Reactions & functional group transformation. Good knowledge of molarity, normality, equivalency. Practical experience in thin-layer chromatography, column purification and extraction. Good understanding of NMR, IR and mass spectrometry. Interest to adapt and knowledge of laboratory safety practices. Enthusiasm to work in a dynamic research environment. Good Soft & Scientific Communication skills. Person Profile Qualification: - M.Sc. in Chemistry/Organic Chemistry/Pharmaceutical Chemistry or related field or M. Pharma (Specialized in Organic Synthesis) with 0-1 years’ project experience. Experience: - 0-1 year of exp. Jubilant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, colour, gender identity or expression, genetic information, marital status, medical condition, national origin, political affiliation, race, ethnicity, religion or any other characteristic protected by applicable local laws, regulations and ordinances. Show more Show less

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5.0 years

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Telangana, India

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Summary As a Principal Scientist I within Preclinical Safety (PCS) Pathology Team, you will be responsible for advancing translational safety omics data analysis to support innovative drug discovery & development efforts. The candidate will participate in the study design, analysis, interpretation, and presentation of the data by interacting closely with a team of pathologists, bench scientists, and subject matter experts across the sites (e.g. USA, Switzerland) of Novartis. The role requires significant omics-based data science expertise and a passion to elevate the role of multimodal data analysis in translational drug safety. About The Role Your responsibilities include, but are not limited to: Use machine learning and statistical methods for analysis of spatial transcriptomics (e.g. Visium/Nanostring platforms) and spatial proteomics data (both internal and public data) from raw reads Compare and contrast spatial omics data sets with bulk RNASeq and single cell data Multimodal analysis of omics data with other modalities such as histopathology images, clinical biomarkers, etc. Support projects with data science expertise in diverse scientific fields such as gene and cell therapy, target discovery, genetics, drug safety, compound screening, etc. Innovate by transforming the way to solve a problem using Data Science & Artificial Intelligence Communicating regularly with stakeholders and assisting with answering their questions with the data and analytics Proactively evaluate the need of technology and novel scientific software, visualization tools and new approaches to computation to increase efficiency and quality of the Novartis data sciences approaches Independently identifies research articles and reproduce/apply methodology to Novartis business problems M.S. or PhD in Data Science, Computational Biology, Bioinformatics, or a related discipline Proficient in programming languages and data science workflows (e.g. Python, R, Git, UNIX command line, high-performance computing (HPC) clusters etc.) A minimum of 5 years of experience in analyzing large biological datasets (genomics, proteomics, and transcriptomics data analysis and data-integration) in a drug discovery/development or relevant academic setting Proven ability to implement exploratory data analysis and statistical inference in the context of scientific research A collaborative, team-focused mindset coupled with outstanding communication skills, and the ability to work in an agile environment Experience with using machine learning algorithms to extract insights from complex datasets Familiarity with the concepts of molecular biology, cell biology, genomics, biostatistics and toxicology WHY NOVARTIS 769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Commitment To Diversity & Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve. Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

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5.0 years

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Noida, Uttar Pradesh, India

Remote

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We are looking for Team Manager Pharmacovigilance to join our team in India on a permanent basis. All over the world, decision-makers depend on us for the essential knowledge that can justify their strategies, promote outstanding research and business growth, and keep them abreast of the market. You’ll join our Life Sciences & Healthcare Pharmacovigilance team responsible for the curation of drug safety information collected from journals, congress publications and drug regulatory approvals which are delivered to OFF-X, a translational drug safety intelligence portal that allows users to easily identify new drug and target safety liabilities. About You – Experience, Education, Skills, And Accomplishments Degree in Life Sciences (Toxicology, Pharmacology, Biology, Pharmacy, Biomedical Sciences, etc.) and experience in pharmacovigilance, drug safety management and/or toxicology At least 5 years’ experience in a global corporation (pharma domain or consulting) with people and process management experience Excellent written and oral communication skills in English. It would be great if you also had . . . Demonstrated ability to work collaboratively in a matrixed organization. Good judgment in decision-making and priority setting. Ability to analyze processes, identify problems, and develop effective solutions. Capability to work remotely with peers in an international environment. Ability to delve deep into content and results. What will you be doing in this role? Create a culture of success, motivating, and developing colleagues to achieve their full potential. Drive execution and performance. Ensure key performance indicators for quality, timeliness and completeness are delivered and strive for continuous improvement. Build a customer-focused team and develop an environment which stimulates innovation. Play a role in major decisions and initiatives to enable the Content Function to achieve its long-term objectives. Communicate initiatives to senior management, set timelines and manage expectations for all deliverables and releases. Work together with Product, Product Operations, Technology and Marketing in the product development process Identify opportunities for synergies and simplification of complex processes. About The Team You’ll be reporting to the Director, Content Editing, based in France and join an international and diverse team of more than 80 colleagues mostly based in Spain and India The OFF-X team is composed of around 20 colleagues mostly based in India The team culture is dynamic, creative, and supportive – excellence, integrity, and care are in our DNA. You’ll have 40 annual paid hours of volunteering time and the chance of being part of an active volunteering community which promotes diversity and inclusion across the business. Hours of Work 40 hours in a week as an FTE Location - Chennai and Noida At Clarivate, we are committed to providing equal employment opportunities for all persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations. Show more Show less

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60.0 years

0 Lacs

Mumbai, Maharashtra, India

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Sales Rep. with a scientific background (BBSC) with an interest in chemistry and HSE Experience in sales mainly for the Maharashtra region. Main Office: Mumbai Parel Office: Home office ABOUT PREVOR - HSE Solutions PREVOR, a French laboratory, has been focusing for the past 60 years on researching toxicology and developing unique solutions to manage chemical risks. Our main achievement is Diphoterine®, a unique, patented first aid solution which, when used right after a chemical splash (acids & alkalis, reducing and oxidizing, chelating agents, and solvents), can significantly mitigate the severity of a burn, and deactivate all chemical reactions. Diphoterine® is increasingly recognized as the most efficient solution to prevent chemical burns and avoid serious medical consequences after a chemical splash in manufacturing units. Present in over 48 countries, Diphoterine® is recommended by national health services in France, UK, and Germany in official guidelines. With a presence of over 15 years in India, our company has earned an outstanding reputation with occupational health practitioners and Safety engineers in over 500 companies. Main website: www.prevor.com PREVOR in India: www.hsesolutions.in To further increase our presence in Indian industries facing chemical risks, we are looking for an experienced head of sales based in Mumbai (office in Parel). As the company is fast growing in India, you must be independent, hardworking, and reliable. Many business trips are involved for sales in Mumbai region (on average at least 3-4 days per week) + team meetings in Mumbai every two weeks. You will receive training in two stages: firstly, to understand PREVOR solutions, and secondly, to master our sales, management, and decision-making methods. As a salesman, you would work closely with the sales manager based in Mumbai. Your responsibilities will then be: To develop PREVOR’s business : You will analyze and understand customers' problems and needs and propose the most appropriate solutions. With your hands-on experience, you'll be able to assess chemical risks on site, and position yourself as the natural contact for specifiers and opinion leaders in your sector. You'll become a real ambassador for our offer at trade shows, professional conventions, scientific seminars, etc. Industry: pharma & all industries using chemicals in their manufacturing processes Some customers: Pharma: Sunpharma, Lupin, Cipla, Teva, Ipca, Sandoz etc… Photovoltaic industry: Jupitar Solar, Adani etc Chemical: Reliance, Atul, Jubilant, SI Group, Lonsen Kiri, Aarti, Srf etc Fertilizers: RCF, Deepak fertilizers, UPL etc. Mining: Vedanta, Hindustan Zinc; Pre-requisites: Degree in chemistry (BSC) minimum Interest / experience in sales (>2 year), Good interaction skills with people Fluency in both oral and written English + Hindi + Marathi In return, high rewards, respect and internal promotion are to be expected. Salary: depending on experience + commissions on sales 3% of the new clients + targets Finally, our company ethics insists on punctuality, seriousness, and hard work. Starting date: Immediately A background check will be done by our recruitment team. Show more Show less

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60.0 years

0 Lacs

Mumbai, Maharashtra, India

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Adviser/ Trainer for safety products and chemical risk management Main Office: Mumbai Parel Office: Home office ABOUT PREVOR - HSE Solutions PREVOR, a French laboratory, has been focusing for the past 60 years on researching toxicology and developing unique solutions to manage chemical risks. Our main achievement is Diphoterine®, a unique, patented first aid solution which, when used right after a chemical splash (acids & alkalis, reducing and oxidizing, chelating agents, and solvents), can significantly mitigate the severity of a burn, and deactivate all chemical reactions. Diphoterine® is increasingly recognized as the most efficient solution to prevent chemical burns and avoid serious medical consequences after a chemical splash in manufacturing units. Present in over 48 countries, Diphoterine® is recommended by national health services in France, UK, and Germany in official guidelines. With a presence of over 10 years in India, our company has earned an outstanding reputation with occupational health practitioners and Safety engineers in over 500 companies. Main website: www.prevor.com PREVOR in India: www.hsesolutions.in First, you you'll receive a training to understand PREVOR products and how they act on chemical burns, then Your responsibilities will be: Train our clients' staff for prevention and treatment of chemical accidents. Introduce the different products and devices that we market to customers (technical side) - Decontamination and environment. Work in PREVOR’s way. It means find the clients’ needs to offer the best solution without being pushy. You will learn our sales and training technics when you will integrate the company. But also, you: Participate at the various events organized by the service (salons, congresses, etc.) Co-work with the commercial department Your profile: You have an experience as an adviser or a trainer in safety or HSE environment (3 to 5 years) Industry: pharma & all industries using chemicals in their manufacturing processes Some customers: Pharma: Sunpharma, Lupin, Cipla, Teva, Ipca, Sandoz etc… Photovoltaic industry: Jupitar Solar, Adani etc Chemical: Reliance, Atul, Jubilant, SI Group, Lonsen Kiri, Aarti, Srf etc Fertilizers: RCF, Deepak fertilizers, UPL etc. Mining: Vedanta, Hindustan Zinc; Your profile: You have a scientific background at engineer level with a specialization in, chemistry, pharmacy, health care… Knowledge and/or experience in the field of first aid, emergency medicine or firefighter would be an advantage. You have teaching skills, and you communicate easily. You are performance oriented. You like to work in a team. You are willing to travel 3 to 4 days per week to cover your zone Fluency in both oral and written English and Marathi In return, high rewards, respect and internal promotion are to be expected. Salary: depending on experience Finally, our company ethics insists on punctuality, seriousness, and hard work. Starting date: Immediately A background check will be done by our recruitment team. Show more Show less

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3.0 years

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Pune, Maharashtra, India

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The Regulatory Medical Writer collaborates with the Medical Writing team and clients to prepare high-quality regulatory documents (Investigators Brochures, Safety Narratives, protocols, investigator brochures, synopses, etc.). The Regulatory Medical Writer is responsible for providing clinical regulatory document support and scientific writing expertise to the clinical teams, ensuring successful preparation of high-quality submission-ready documents and effective implementation of the writing process. The Regulatory Medical Writer will also be responsible for the expanded development, implementation, and maintenance of operations related to clinical trial registration and results disclosure. The Regulatory Medical Writer will ensure effective and clear communication of technical information in scientific regulatory documentation writing. The role provides medical writing expertise for multiple compounds and/or projects within a therapeutic area, and interfaces with external groups (e.g. PK, Toxicology, e-Submissions, Regulatory, Statistical Support, Data Management) and client teams to ensure accurate and timely completion/delivery of information and review of clinical regulatory documents. RESPONSIBILITIES Provide overall medical writing support for ongoing projects. Preparation of clinical study-related documents, such as protocols, protocol amendments, clinical study reports, or other regulatory documents supporting ongoing clinical development programs Direct performance of authoring for clinical trial results disclosure on ClinicalTrials.gov, EudraCT, ENCEPP, or similar platforms, including initial drafting, collaborative review and revision, quality control activities, approval, and release/publication for public disclosure Proactive management of project timelines, ensuring that all relevant timelines are communicated, working cross-functionally, meeting required deadlines, maintenance of document archives, and updating project tracking systems Responsible for effective communication among team members and identifying and resolving conflicts to ensure teams achieve project goals Understand and comply with appropriate conventions and other governing bodies following applicable divisional guidelines, templates, and SOPs Quality-checking documents for agreement between in-text information and the source data, and for internal consistency Maintain knowledge of US, EU, and other international regulations (gains and maintains certifications) Act as Subject Matter Expert in eDocs, eCTD Development, implementation, and maintenance of operations related to sponsor’s clinical trial results disclosure throughout each product’s development lifecycle Recommend tactical process improvements, both within the department and division-wide Occasional international and domestic travel required for industry-related conferences Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor REQUIRED SKILLS, EXPERIENCE AND QUALIFICATIONS Masters or PhD in science discipline Preferred – American Medical Writing Association (AMWA), European Medical Writing Association (EMWA), or International Society for Medical Publication Professionals (ISMPP) certification Thorough understanding of ICH, GLP, GCP, GMP, and style guide standard compliance 3-5 years of relevant industry experience in medical writing Creative thinker – Curious and unafraid to ask questions Hard worker – Industrious and diligent in everything you do Innovator – Willing to initiate changes and introduce new ideas Client-facing Excellent written and oral communication skills Extensive knowledge of English grammar and spelling, as well as medical terminology DESIRED SKILLS, EXPERIENCE AND QUALIFICATIONS Experience writing high-level content for clinical publications or clinical regulatory documents Experience in assimilation and interpretation of scientific content Working knowledge of statistical concepts and techniques Advanced experience in word processing, flow diagrams, and spreadsheets Experience in working with collaborative, cross-functional teams Proficiency in Word, PowerPoint, Excel, Outlook, and scientific databases including PubMed, Embase, etc. About Us: For more than 20 years, TransPerfect has provided comprehensive language and technology solutions to help our clients communicate and conduct business more effectively in a global marketplace. Equipped with a quality management system certified to both the ISO 9001:2015 and ISO 17100:2015 standards, TransPerfect provides a full array of language and business support services, including translation, interpretation, multicultural marketing, website globalization, subtitling, voiceovers, staffing services, multicultural marketing, e-learning and training, and legal support services. TransPerfect also offers a suite of next-generation technologies that significantly reduce costs and improve consistency throughout the translation process, making TransPerfect the vendor of choice for the world's leading multinationals. TransPerfect Life Sciences Solutions has helped life sciences companies conduct clinical development and commercialize products on a global scale. We bring that same level of expertise to our secure, web-based e-clinical solution, Trial Interactive. Trial Interactive enables life sciences companies to streamline the execution and commercialization of global clinical trials and collaborate on partnerships while reducing administrative burdens. With annual revenues of over $550 million, TransPerfect is the world's largest privately held provider of language services and technology solutions. From offices in more than 90 cities on six continents, TransPerfect offers a full range of services in 170+ languages to clients worldwide. With an unparalleled commitment to quality and client service, TransPerfect is fully ISO 9001 and ISO 17100 certified. TransPerfect has global headquarters in New York, with regional headquarters in London and Hong Kong. Show more Show less

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3.0 years

3 - 7 Lacs

Bengaluru

On-site

Location: Bengaluru, KA, IN Company: ExxonMobil About us At ExxonMobil, our vision is to lead in energy innovations that advance modern living and a net-zero future. As one of the world’s largest publicly traded energy and chemical companies, we are powered by a unique and diverse workforce fueled by the pride in what we do and what we stand for. The success of our Upstream, Product Solutions and Low Carbon Solutions businesses is the result of the talent, curiosity and drive of our people. They bring solutions every day to optimize our strategy in energy, chemicals, lubricants and lower-emissions technologies. We invite you to bring your ideas to ExxonMobil to help create sustainable solutions that improve quality of life and meet society’s evolving needs. Learn more about our What and our Why and how we can work together . ExxonMobil’s affiliates in India ExxonMobil’s affiliates have offices in India in Bengaluru, Mumbai and the National Capital Region. ExxonMobil’s affiliates in India supporting the Product Solutions business engage in the marketing, sales and distribution of performance as well as specialty products across chemicals and lubricants businesses. The India planning teams are also embedded with global business units for business planning and analytics. ExxonMobil’s LNG affiliate in India supporting the upstream business provides consultant services for other ExxonMobil upstream affiliates and conducts LNG market-development activities. The Global Business Center - Technology Center provides a range of technical and business support services for ExxonMobil’s operations around the globe. ExxonMobil strives to make a positive contribution to the communities where we operate, and its affiliates support a range of education, health and community-building programs in India. Read more about our Corporate Responsibility Framework. To know more about ExxonMobil in India, visit ExxonMobil India and the Energy Factor India. What role you will play in our team Business compliance Advisor is responsible for engaging with EMPS Sales and Marketing & Technology functions to assess and develop Safety Data Sheets (SDS), Product Regulatory Statements, & related Chemical Management information to support our customers and maintain compliance across the markets and segments we operate. The support provides our employees and customers in the safe cradle-to-grave handling of our products as well as compliance with the Corporate Product Safety Policy and regulations in the countries in which we do business. In addition, the BCA provides insight to the rapidly evolving regulatory frameworks to the business lines to inform product design and marketing strategies What you will do Leadership in PS&RA Surveillance Activities Surveillance : Monitor emerging, new, and changing product SHE (Safety, Health, and Environment) regulations through various channels. Evaluation and Interpretation : Assess the impact of these regulations on Product Solutions. Documentation : Maintain up-to-date surveillance logs. Enabling Business Competitiveness and Compliance Regulatory Expertise : Provide technical regulatory expertise and align on interpretation of regulatory requirements. Compliance Support : Ensure compliance with regulations in assigned geographies and interface with other teams for consistent interpretation and timely compliance. Regulatory Compliance Activities Communication : Provide tailored communication to internal and external customers. Safety Data Sheets : Add local regulations to finalize safety data sheets. Product Management : Process product management of change requests and perform product registrations in national registers. Reporting : Conduct sales volume and GHS (Globally Harmonized System) reporting to authority websites. Poison Center Updates : Analyze and process needs for poison center updates. Salesforce Compliance Portal : Manage the portal to ensure prompt feedback on regulatory questions. Safety Data Sheet Distribution : Check distribution reports and initiate corrective actions if needed. Database Management : Manage databases for representative agreements or REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) registrations. About you Skills and Qualifications Bachelor’s or MSc (Toxicology/Microbiology) with 7 CGPA Minimum 3 years of industry experience Willing to work in shifts (9.00 AM – 6.00 PM IST) Familiarity with regulations for Chemical Classification and Labelling and Product Transportation Classification Your benefits An ExxonMobil career is one designed to last. Our commitment to you runs deep: our employees grow personally and professionally, with benefits built on our core categories of health, security, finance and life. We offer you: Competitive compensation Medical plans, maternity leave and benefits, life, accidental death and dismemberment benefits Retirement benefits Global networking & cross-functional opportunities Annual vacations & holidays Day care assistance program Training and development program Tuition assistance program Workplace flexibility policy Relocation program Transportation facility Please note benefits may change from time to time without notice, subject to applicable laws. The benefits programs are based on the Company’s eligibility guidelines. Stay connected with us Learn more about ExxonMobil in India, visit ExxonMobil India and Energy Factor India. Follow us on LinkedIn and Instagram Like us on Facebook Subscribe our channel at YouTube EEO Statement ExxonMobil is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin or disability status. Business solicitation and recruiting scams ExxonMobil does not use recruiting or placement agencies that charge candidates an advance fee of any kind (e.g., placement fees, immigration processing fees, etc.). Follow the LINK to understand more about recruitment scams in the name of ExxonMobil. Nothing herein is intended to override the corporate separateness of local entities. Working relationships discussed herein do not necessarily represent a reporting connection, but may reflect a functional guidance, stewardship, or service relationship. Exxon Mobil Corporation has numerous affiliates, many with names that include ExxonMobil, Exxon, Esso and Mobil. For convenience and simplicity, those terms and terms like corporation, company, our, we and its are sometimes used as abbreviated references to specific affiliates or affiliate groups. Abbreviated references describing global or regional operational organizations and global or regional business lines are also sometimes used for convenience and simplicity. Similarly, ExxonMobil has business relationships with thousands of customers, suppliers, governments, and others. For convenience and simplicity, words like venture, joint venture, partnership, co-venturer, and partner are used to indicate business relationships involving common activities and interests, and those words may not indicate precise legal relationships. Job Segment: Sustainability, Chemical Research, CSR, Database, Energy, Engineering, Management, Technology

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1.0 years

5 - 8 Lacs

Bengaluru

On-site

Location: Bengaluru, KA, IN Company: ExxonMobil About us At ExxonMobil, our vision is to lead in energy innovations that advance modern living and a net-zero future. As one of the world’s largest publicly traded energy and chemical companies, we are powered by a unique and diverse workforce fueled by the pride in what we do and what we stand for. The success of our Upstream, Product Solutions and Low Carbon Solutions businesses is the result of the talent, curiosity and drive of our people. They bring solutions every day to optimize our strategy in energy, chemicals, lubricants and lower-emissions technologies. We invite you to bring your ideas to ExxonMobil to help create sustainable solutions that improve quality of life and meet society’s evolving needs. Learn more about our What and our Why and how we can work together . ExxonMobil’s affiliates in India ExxonMobil’s affiliates have offices in India in Bengaluru, Mumbai and the National Capital Region. ExxonMobil’s affiliates in India supporting the Product Solutions business engage in the marketing, sales and distribution of performance as well as specialty products across chemicals and lubricants businesses. The India planning teams are also embedded with global business units for business planning and analytics. ExxonMobil’s LNG affiliate in India supporting the upstream business provides consultant services for other ExxonMobil upstream affiliates and conducts LNG market-development activities. The Global Business Center - Technology Center provides a range of technical and business support services for ExxonMobil’s operations around the globe. ExxonMobil strives to make a positive contribution to the communities where we operate and its affiliates support a range of education, health and community-building programs in India. Read more about our Corporate Responsibility Framework. To know more about ExxonMobil in India, visit ExxonMobil India and the Energy Factor India. What role you will play in our team The Global Hazard Communication Advisor is responsible for delivering Safety Data Sheets (SDS) and related Chemical Management information to support the ExxonMobil Product Safety Policy and regulatory compliance globally The Specialist covers related functions including SDS Authoring, applied toxicology for chemical classification, product stewardship and regulatory interpretation, and related information-management-system support The position works closely with Marketing, Technology, and Regulatory Advisors What you will do Plan and execute SDS and related projects in coordination with business teams and stakeholders Work within established processes to assemble information and publish SDS Assign exposure scenarios and risk management measures for EU-REACH extended SDS development Read and interpret Hazard Communication regulations to determine impacts on product classification and labelling Support business partners in assessing new or reformulated products for classification and labelling purposes Evaluate new chemical classifications and maintain current and accurate data for SDS development Support the Product Stewardship Information Management System functions and interfaces with other systems Utilize software tools to classify product hazards based on composition, physical and chemical properties, and applicable chemical control regulations Support EU REACH product safety dossier development and submission using various tools such as IUCLID Identify and promote continuous improvement opportunities in systems and procedures About You Skills and Qualification BE / B Tech (Chemical / Materials / Polymers / Petroleum) or Masters in Pharmacology, Chemistry, Engineering, or other science discipline with minimum CGPA 6.5 or 65% Minimum 1 years of experience in petrochemical laboratories, or experience in product stewardship, toxicology, or chemical safety function Experience in SDS Authoring is required REACH Regulations is must IT System and Product Stewardship data management experience strongly preferred Preferred Skills and Qualifications Understanding of physical and chemical properties such as density, viscosity, and flash point Familiarity with regulations for Chemical Classification and Labelling and Product Transportation Classification Strong English communication skills Familiarity with common software including MS Excel, Word, PowerPoint Self motivated with ability to work independently and with global teams Well organized with attention to detail and concern for accuracy Your benefits An ExxonMobil career is one designed to last. Our commitment to you runs deep: our employees grow personally and professionally, with benefits built on our core categories of health, security, finance and life. We offer you: Competitive compensation Medical plans, maternity leave and benefits, life, accidental death and dismemberment benefits Retirement benefits Global networking & cross-functional opportunities Annual vacations & holidays Day care assistance program Training and development program Tuition assistance program Workplace flexibility policy Relocation program Transportation facility Please note benefits may change from time to time without notice, subject to applicable laws. The benefits programs are based on the Company’s eligibility guidelines. Stay connected with us Learn more about ExxonMobil in India, visit ExxonMobil India and Energy Factor India. Follow us on LinkedIn and Instagram Like us on Facebook Subscribe our channel at YouTube EEO Statement ExxonMobil is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin or disability status. Business solicitation and recruiting scams ExxonMobil does not use recruiting or placement agencies that charge candidates an advance fee of any kind (e.g., placement fees, immigration processing fees, etc.). Follow the LINK to understand more about recruitment scams in the name of ExxonMobil. Nothing herein is intended to override the corporate separateness of local entities. Working relationships discussed herein do not necessarily represent a reporting connection, but may reflect a functional guidance, stewardship, or service relationship. Exxon Mobil Corporation has numerous affiliates, many with names that include ExxonMobil, Exxon, Esso and Mobil. For convenience and simplicity, those terms and terms like corporation, company, our, we and its are sometimes used as abbreviated references to specific affiliates or affiliate groups. Abbreviated references describing global or regional operational organizations and global or regional business lines are also sometimes used for convenience and simplicity. Similarly, ExxonMobil has business relationships with thousands of customers, suppliers, governments, and others. For convenience and simplicity, words like venture, joint venture, partnership, co-venturer, and partner are used to indicate business relationships involving common activities and interests, and those words may not indicate precise legal relationships. Job Segment: Sustainability, Chemical Research, Embedded, CSR, Risk Management, Energy, Engineering, Technology, Management, Finance

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0 years

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Vadodara, Gujarat, India

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Company Description JDM Research is a state-of-the-art, fully integrated contract research organisation having ISO 17025, GLP and DSIR accreditations to conduct research and analytical testing in the field of Chemicals, Agrochemicals, Bio-pesticides, Pharmaceuticals, Fine Chemicals, Medical Devices, Biotechnology, Nutrition, etc. Powered by more than 130 highly skilled and experienced scientists and specialists, we provide solutions to our clients from inception of the project to its completion enabling them to meet entire regulatory needs. The facility, located near to Vadodara, Gujarat, India, is spread over more than 10 acres with 120,000 sq. feet built-up area. The organisation has diversified into R&D services, development of production technologies at Lab Level to scale-up up to pilot plant levels, regulatory data generation in the disciplines of Chemistry, Efficacy, Residues, Toxicology, Environmental Fate and Metabolism. Role Description This is a full-time Apprentice role located in Vadodara. The role will involve day-to-day tasks related to assisting in Admin-HR and Accounts, Business Departments , learning about different CRO processes. Qualifications Ability to work in a fast-paced environment and willingness to learn Good communication and interpersonal skills Basic computer skills and MS Office, B.com or equivalent Degree Must Be fresher Show more Show less

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10.0 years

0 Lacs

Bengaluru, Karnataka, India

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About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role We have a opportunity for a Medical Device Assessor/ Auditor to join our India Team. The successful candidate will be responsible for, planning and conducting audits/ assessments, in accordance with ISO 13485, EU MDR, and MDSAP standards and related (eg IMDR). Key Accountabilities Technical Compliances, Accreditation Requirements and collaborating with a Team of Auditors/ Assessors. Conduct audits (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to medical device procedures, processes, systems and documentation. If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. To be considered for this role, you’ll require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs: work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies. work in the application of device technology and its use in health care services and with patients. testing devices for compliance with the relevant national or international standards. conducting performance testing, evaluation studies or clinical trials of devices. 5 + years relevant professional experience in quality management is essential. In addition to the above you’ll also need to demonstrate the following. An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application Knowledge of MDR 2017/745, MDSAP, IMDR Work experience in positions with significant QA, Regulatory or management systems responsibility Experience with Harmonized medical device standards and for active & non active devices. Experience with Risk Management EN ISO 14971 Experience auditing against recognized standards Experience of working under own initiative and in planning and prioritizing workloads Solid knowledge of non-active devices Solid knowledge of sterilization processes The Following Attributes Are Essential Work actively with a Team of Assessors/ Auditors. Experience of reviewing audit packs Review of technical documentation Registered IRCA lead auditor, or equivalent registration under other recognized body What we offer Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Computer & Software Technology, Engineering, Nursing, Quality Management. Qualified MDR Assessor from a reputed EU Notified Body, desirable. Experience with scientific literature searches or peer review in the medical context. Fluent in written and spoken English. Experience working with Various Digital Tools. Excellent organizational and professional communication skills. Show more Show less

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10.0 years

0 Lacs

Hyderabad, Telangana, India

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About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role We have a opportunity for a Medical Device Assessor/ Auditor to join our India Team. The successful candidate will be responsible for, planning and conducting audits/ assessments, in accordance with ISO 13485, EU MDR, and MDSAP standards and related (eg IMDR). Key Accountabilities Technical Compliances, Accreditation Requirements and collaborating with a Team of Auditors/ Assessors. Conduct audits (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to medical device procedures, processes, systems and documentation. If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. To be considered for this role, you’ll require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs: work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies. work in the application of device technology and its use in health care services and with patients. testing devices for compliance with the relevant national or international standards. conducting performance testing, evaluation studies or clinical trials of devices. 5 + years relevant professional experience in quality management is essential. In addition to the above you’ll also need to demonstrate the following. An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application Knowledge of MDR 2017/745, MDSAP, IMDR Work experience in positions with significant QA, Regulatory or management systems responsibility Experience with Harmonized medical device standards and for active & non active devices. Experience with Risk Management EN ISO 14971 Experience auditing against recognized standards Experience of working under own initiative and in planning and prioritizing workloads Solid knowledge of non-active devices Solid knowledge of sterilization processes The Following Attributes Are Essential Work actively with a Team of Assessors/ Auditors. Experience of reviewing audit packs Review of technical documentation Registered IRCA lead auditor, or equivalent registration under other recognized body What we offer Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Computer & Software Technology, Engineering, Nursing, Quality Management. Qualified MDR Assessor from a reputed EU Notified Body, desirable. Experience with scientific literature searches or peer review in the medical context. Fluent in written and spoken English. Experience working with Various Digital Tools. Excellent organizational and professional communication skills. Show more Show less

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10.0 years

0 Lacs

Delhi, India

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About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role We have a opportunity for a Medical Device Assessor/ Auditor to join our India Team. The successful candidate will be responsible for, planning and conducting audits/ assessments, in accordance with ISO 13485, EU MDR, and MDSAP standards and related (eg IMDR). Key Accountabilities Technical Compliances, Accreditation Requirements and collaborating with a Team of Auditors/ Assessors. Conduct audits (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to medical device procedures, processes, systems and documentation. If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. To be considered for this role, you’ll require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs: work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies. work in the application of device technology and its use in health care services and with patients. testing devices for compliance with the relevant national or international standards. conducting performance testing, evaluation studies or clinical trials of devices. 5 + years relevant professional experience in quality management is essential. In addition to the above you’ll also need to demonstrate the following. An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application Knowledge of MDR 2017/745, MDSAP, IMDR Work experience in positions with significant QA, Regulatory or management systems responsibility Experience with Harmonized medical device standards and for active & non active devices. Experience with Risk Management EN ISO 14971 Experience auditing against recognized standards Experience of working under own initiative and in planning and prioritizing workloads Solid knowledge of non-active devices Solid knowledge of sterilization processes The Following Attributes Are Essential Work actively with a Team of Assessors/ Auditors. Experience of reviewing audit packs Review of technical documentation Registered IRCA lead auditor, or equivalent registration under other recognized body What we offer Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Computer & Software Technology, Engineering, Nursing, Quality Management. Qualified MDR Assessor from a reputed EU Notified Body, desirable. Experience with scientific literature searches or peer review in the medical context. Fluent in written and spoken English. Experience working with Various Digital Tools. Excellent organizational and professional communication skills. Show more Show less

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10.0 years

0 Lacs

Pune, Maharashtra, India

On-site

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About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role We have a opportunity for a Medical Device Assessor/ Auditor to join our India Team. The successful candidate will be responsible for, planning and conducting audits/ assessments, in accordance with ISO 13485, EU MDR, and MDSAP standards and related (eg IMDR). Key Accountabilities Technical Compliances, Accreditation Requirements and collaborating with a Team of Auditors/ Assessors. Conduct audits (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to medical device procedures, processes, systems and documentation. If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. To be considered for this role, you’ll require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs: work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies. work in the application of device technology and its use in health care services and with patients. testing devices for compliance with the relevant national or international standards. conducting performance testing, evaluation studies or clinical trials of devices. 5 + years relevant professional experience in quality management is essential. In addition to the above you’ll also need to demonstrate the following. An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application Knowledge of MDR 2017/745, MDSAP, IMDR Work experience in positions with significant QA, Regulatory or management systems responsibility Experience with Harmonized medical device standards and for active & non active devices. Experience with Risk Management EN ISO 14971 Experience auditing against recognized standards Experience of working under own initiative and in planning and prioritizing workloads Solid knowledge of non-active devices Solid knowledge of sterilization processes The Following Attributes Are Essential Work actively with a Team of Assessors/ Auditors. Experience of reviewing audit packs Review of technical documentation Registered IRCA lead auditor, or equivalent registration under other recognized body What we offer Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Computer & Software Technology, Engineering, Nursing, Quality Management. Qualified MDR Assessor from a reputed EU Notified Body, desirable. Experience with scientific literature searches or peer review in the medical context. Fluent in written and spoken English. Experience working with Various Digital Tools. Excellent organizational and professional communication skills. Show more Show less

Posted 2 weeks ago

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10.0 years

0 Lacs

Mumbai Metropolitan Region

On-site

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About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role We have a opportunity for a Medical Device Assessor/ Auditor to join our India Team. The successful candidate will be responsible for, planning and conducting audits/ assessments, in accordance with ISO 13485, EU MDR, and MDSAP standards and related (eg IMDR). Key Accountabilities Technical Compliances, Accreditation Requirements and collaborating with a Team of Auditors/ Assessors. Conduct audits (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to medical device procedures, processes, systems and documentation. If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. To be considered for this role, you’ll require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs: work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies. work in the application of device technology and its use in health care services and with patients. testing devices for compliance with the relevant national or international standards. conducting performance testing, evaluation studies or clinical trials of devices. 5 + years relevant professional experience in quality management is essential. In addition to the above you’ll also need to demonstrate the following. An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application Knowledge of MDR 2017/745, MDSAP, IMDR Work experience in positions with significant QA, Regulatory or management systems responsibility Experience with Harmonized medical device standards and for active & non active devices. Experience with Risk Management EN ISO 14971 Experience auditing against recognized standards Experience of working under own initiative and in planning and prioritizing workloads Solid knowledge of non-active devices Solid knowledge of sterilization processes The Following Attributes Are Essential Work actively with a Team of Assessors/ Auditors. Experience of reviewing audit packs Review of technical documentation Registered IRCA lead auditor, or equivalent registration under other recognized body What we offer Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Computer & Software Technology, Engineering, Nursing, Quality Management. Qualified MDR Assessor from a reputed EU Notified Body, desirable. Experience with scientific literature searches or peer review in the medical context. Fluent in written and spoken English. Experience working with Various Digital Tools. Excellent organizational and professional communication skills. Show more Show less

Posted 2 weeks ago

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10.0 years

0 Lacs

Ahmedabad, Gujarat, India

On-site

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About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role We have a opportunity for a Medical Device Assessor/ Auditor to join our India Team. The successful candidate will be responsible for, planning and conducting audits/ assessments, in accordance with ISO 13485, EU MDR, and MDSAP standards and related (eg IMDR). Key Accountabilities Technical Compliances, Accreditation Requirements and collaborating with a Team of Auditors/ Assessors. Conduct audits (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to medical device procedures, processes, systems and documentation. If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. To be considered for this role, you’ll require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs: work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies. work in the application of device technology and its use in health care services and with patients. testing devices for compliance with the relevant national or international standards. conducting performance testing, evaluation studies or clinical trials of devices. 5 + years relevant professional experience in quality management is essential. In addition to the above you’ll also need to demonstrate the following. An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application Knowledge of MDR 2017/745, MDSAP, IMDR Work experience in positions with significant QA, Regulatory or management systems responsibility Experience with Harmonized medical device standards and for active & non active devices. Experience with Risk Management EN ISO 14971 Experience auditing against recognized standards Experience of working under own initiative and in planning and prioritizing workloads Solid knowledge of non-active devices Solid knowledge of sterilization processes The Following Attributes Are Essential Work actively with a Team of Assessors/ Auditors. Experience of reviewing audit packs Review of technical documentation Registered IRCA lead auditor, or equivalent registration under other recognized body What we offer Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Computer & Software Technology, Engineering, Nursing, Quality Management. Qualified MDR Assessor from a reputed EU Notified Body, desirable. Experience with scientific literature searches or peer review in the medical context. Fluent in written and spoken English. Experience working with Various Digital Tools. Excellent organizational and professional communication skills. Show more Show less

Posted 2 weeks ago

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10.0 years

0 Lacs

Chennai, Tamil Nadu, India

On-site

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About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role We have a opportunity for a Medical Device Assessor/ Auditor to join our India Team. The successful candidate will be responsible for, planning and conducting audits/ assessments, in accordance with ISO 13485, EU MDR, and MDSAP standards and related (eg IMDR). Key Accountabilities Technical Compliances, Accreditation Requirements and collaborating with a Team of Auditors/ Assessors. Conduct audits (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to medical device procedures, processes, systems and documentation. If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. To be considered for this role, you’ll require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs: work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies. work in the application of device technology and its use in health care services and with patients. testing devices for compliance with the relevant national or international standards. conducting performance testing, evaluation studies or clinical trials of devices. 5 + years relevant professional experience in quality management is essential. In addition to the above you’ll also need to demonstrate the following. An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application Knowledge of MDR 2017/745, MDSAP, IMDR Work experience in positions with significant QA, Regulatory or management systems responsibility Experience with Harmonized medical device standards and for active & non active devices. Experience with Risk Management EN ISO 14971 Experience auditing against recognized standards Experience of working under own initiative and in planning and prioritizing workloads Solid knowledge of non-active devices Solid knowledge of sterilization processes The Following Attributes Are Essential Work actively with a Team of Assessors/ Auditors. Experience of reviewing audit packs Review of technical documentation Registered IRCA lead auditor, or equivalent registration under other recognized body What we offer Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Computer & Software Technology, Engineering, Nursing, Quality Management. Qualified MDR Assessor from a reputed EU Notified Body, desirable. Experience with scientific literature searches or peer review in the medical context. Fluent in written and spoken English. Experience working with Various Digital Tools. Excellent organizational and professional communication skills. Show more Show less

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