139 Cmc Jobs - Page 3

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Bilaspur. The ideal candidate will have 2-5 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform various tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Supervisor/Manager. Assist in empaneling new vendors and developing relationships with them. Ensure compliance with all Audit/RBI regulations with the help of the Manager/Supervisor. Job Minimum 2 years of experience in customer service, preferably in banking or financial services. Strong knowledge of customer service principles and practices. Excellent communication and interpersonal skills. Ability to work in a fast-paced environment and meet targets. Strong analytical and problem-solving skills. Experience in personal loans, emerging markets, and mix sales is an added advantage. Any graduate can apply for this position. About Company TATA CAPITAL LIMITED is a leading player in the banking and financial services industry, committed to providing exceptional customer experiences and driving business growth.

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Lucknow. The ideal candidate will have 1 to 6 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Supervisor/Manager. Assist in empaneling new vendors and developing relationships with them. Ensure compliance with all Audit/RBI regulations with the help of the Manager/Supervisor. Job Minimum 1 year of experience in customer service, preferably in banking or financial services. Strong knowledge of customer service principles and practices. Excellent communication and interpersonal skills. Ability to work in a fast-paced environment and meet targets. Strong analytical and problem-solving skills. Experience in personal loans, emerging markets, and mix sales is an added advantage. Educational qualificationsAny Graduate or Postgraduate degree. About Company TATA CAPITAL LIMITED is a leading player in the banking and financial services industry, committed to providing exceptional customer experiences and driving business growth.

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Hubli. The ideal candidate will have 2-5 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Supervisor/Manager. Assist in empaneling new vendors and developing relationships with them. Ensure compliance with all Audit/RBI regulations with the help of the Manager/Supervisor. Job Minimum 2 years of experience in customer service, preferably in banking or financial services. Strong knowledge of customer service principles and practices. Excellent communication and interpersonal skills. Ability to work in a fast-paced environment and meet targets. Strong analytical and problem-solving skills. Experience in personal loans, emerging markets, and mix sales is an added advantage. Educational qualificationsAny Graduate or Postgraduate degree. About Company TATA CAPITAL LIMITED is a leading player in the banking and financial services industry, committed to providing exceptional customer service and building long-term relationships with its clients.

We are looking for a highly motivated and results-driven Customer Sales Executive to join our team in Hubli. The ideal candidate will have 2 to 7 years of experience in sales, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products with the guidance of the Supervisor/Manager. Job Minimum 2 years of experience in sales, preferably in banking or financial services. Strong knowledge of audit and RBI regulations. Ability to empanel new vendors and develop relationships with them. Excellent communication and interpersonal skills. Ability to work in a fast-paced environment and meet targets. Any graduate degree is required. Additional Info The company name is TATA CAPITAL LIMITED, and the industry is Banking / Financial Services / Broking.

We are looking for a highly motivated and customer-focused individual with 0 to 3 years of experience to join our team as a Customer Service Executive in Coimbatore. The ideal candidate will have excellent communication skills and the ability to work effectively in a fast-paced environment. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager, including identifying potential business customers. Collect and validate customer documents according to organizational norms. Log cases in the system following SOPs and processes for disbursement. Fulfill sanction ratios as per organizational requirements. Meet customer needs and cross-sell multiple products with the help of the Supervisor/Manager. Empanel new vendors and develop relationships with their help. Job Any Graduate or Postgraduate degree. Strong communication and interpersonal skills. Ability to work in a team and follow instructions from supervisors/managers. Basic knowledge of audit/RBI regulations. Willingness to learn and adapt to new processes and systems. Familiarity with personal loans and emerging markets is an added advantage. Additional Info The company offers a dynamic work environment and opportunities for growth and development.

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Guwahati. The ideal candidate will have 1-3 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Supervisor/Manager. Assist in empaneling new vendors and developing relationships with them. Ensure compliance with all Audit/RBI regulations with the help of the Manager/Supervisor. Job Minimum 1 year of experience in customer service, preferably in banking or financial services. Strong knowledge of customer service principles and practices. Excellent communication and interpersonal skills. Ability to work in a fast-paced environment and meet targets. Strong analytical and problem-solving skills. Experience in personal loans, emerging markets, direct sales, and CSE is an added advantage. Educational qualificationsAny Graduate or Postgraduate degree. About Company TATA CAPITAL LIMITED is a leading player in the banking and financial services industry, committed to providing exceptional customer experiences and driving business growth.

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Lucknow. The ideal candidate will have 1-3 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Supervisor/Manager. Assist in empaneling new vendors and developing relationships with them. Ensure compliance with all Audit/RBI regulations with the help of the Manager/Supervisor. Job Minimum 1 year of experience in customer service, preferably in banking or financial services. Strong knowledge of customer service principles and practices. Excellent communication and interpersonal skills. Ability to work in a fast-paced environment and meet targets. Strong analytical and problem-solving skills. Experience in personal loans, emerging markets, and mix sales is an added advantage. Educational qualificationsAny Graduate or Postgraduate degree. About Company TATA CAPITAL LIMITED is a leading player in the banking and financial services industry, committed to providing exceptional customer service and building long-term relationships with its clients.

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Nagpur. The ideal candidate will have 1-3 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform various tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Supervisor/Manager. Assist in empaneling new vendors and developing relationships with them. Ensure compliance with all Audit/RBI regulations with the help of the Manager/Supervisor. Job Minimum 1 year of experience in customer service, preferably in banking or financial services. Strong knowledge of customer service principles and practices. Excellent communication and interpersonal skills. Ability to work in a fast-paced environment and meet targets. Strong analytical and problem-solving skills. Experience in personal loans, emerging markets, direct sales, and CSE is an added advantage. Any graduate can apply for this position. About Company TATA CAPITAL LIMITED is a leading player in the banking and financial services industry, committed to providing exceptional customer experiences and driving business growth.

The incumbent will be responsible in an individual contributor role for supporting analytical research and development activities (method development, validations, transfers, documentation, stability, etc) for API and drug products. The candidate will be responsible for supporting multiple projects and will work in close collaboration with partner groups across the organization such as global development teams (formulation, chemistry, API scale up, etc), regulatory, quality, manufacturing and clinical organizations as we'll as manage analytical activities outsourced to vendors. The candidate will be responsible for authoring and reviewing various documentations such as specifications, test procedures, method validation plans, protocols, reports, stability data, SOPs, and CMC technical sections for regulatory submission. The candidate will be responsible for projection and effective management of resources to ensure timelines, budgets and deliverables are met as per project requirements. Qualifications M Pharm / M Sc in Analytical / Pharmaceutical Chemistry, or other related discipline with 10-15 years of analytical research experience in Pharmaceutical R&D Essential Skills / Competencies Thorough understanding, knowledge and experience with various modern analytical tools and technologies used in the pharmaceutical industry (eg, U/HPLC, GC, MS, Karl Fischer, dissolution, particle size, etc). Practical analytical experience of working with dosage forms including solids and liquids for oral, topical and parenteral administration. This includes demonstrated experience in the technical areas of stability, characterization / isolation of impurities, and a track record of analytical problem solving. Good knowledge of pre-formulation studies, drug degradation pathways, stress stability designs, stabilization techniques and biopharmaceutical aspects of drug products. Good understanding of analytical quality requirements for clinical supplies and technical transfer activities. Good understanding of the pharmaceutical development process. Good knowledge of Quality by Design (QbD) principles and optimization techniques. Good interpersonal, communication and presentation skills essential for contributing to project teams and influencing decisions. Good documentation skills for recording research and ability to summarize results and data in concise memos, development reports, summaries etc; experience in writing and supporting regulatory documents (eg, validation reports, specifications, stability reports, development summaries, CMC technical sections). Knowledge or interest in data management, FAIR data principles, and data visualization. Other attributes desirable Stay current with new developments in analytical chemistry and their application to development projects. Use knowledge and experience to design, conduct and interpret data from experiments. Plan work independently based on specific objectives. Prioritize tasks; keep management/team informed of progress and adjust work accordingly. Display an understanding of project goals. Demonstrate the ability to identify and recommend solutions for problems that arise in the course of experimentation. Identify and utilize the most reliable resources to get at the root of a problem. Understand safety. Consider safety as an integral part of planning for and performing daily activities. Communicate technical information efficiently and accurately. Practice active listening skills to understand information being communicated by others. Deliver articulate presentations in a team environment. Write clearly and concisely. Maintain laboratory notebook meeting corporate standards. Continuously improve techniques and work processes by introducing imaginative approaches and championing new technologies to improve group/team performance. Recognize the importance of relationships within the work group. Build a sense of partnership with others in the work group to achieve results. Build and maintain a strong network with people from other departments to enhance collaboration on assignments. Work as part of international teams, work with contract research organizations, and have familiarity with the Animal Health industry.

Berger Paints India Ltd ( British Paints Div ) is looking for Area Sales Manager - Prolink to join our dynamic team and embark on a rewarding career journey Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status

Job Description Review of CMC related documents received from various inter functional departments and provide necessary inputs as per regulatory requirements. Preparation of CMC sections, compilation and review of dossiers as per country specific requirements. Track collection of all dossier/information from all concerned departments and ensure submission to regulatory authorities as per the agreed timeframe. Responsible for regulatory impact assessment in QAMS (Lupin biotech, Ghotawade facility). Responsible for preparation and compilation of query responses by coordinating with inter-function teams and submit to regulatory authorities within stipulated timeline. Continually track any changes, variations or process modifications throughout product life cycle and carry out necessary update to documentation in order to comply with all norms. Co-ordinate with respective business partners for various regulatory activities throughout the product life-cycle. Work Experience 7-12 Years of Relevant experience. With team management experience. Education Doctorate in Biotechnology or Pharmacy Masters in Veterinary Science or Biopharmaceutics Competencies 1. Strategic Agility 3. Customer Centricity 4. Developing Talent 5. Result Orientation 6. Process Excellence 8. Stakeholder Management 7. Collaboration

Implement and maintain SAP BusinessObjects (BO) solutions, focusing on report generation, dashboard development, and data visualization. Ensure accurate data representation and enhance decision-making processes for business users.

Skill requirement: Primary Skill --> Business Object 4.2 (Developer and Administrator), Web Intelligence / Crystal Reports, Universe design, CMC, CMS and Oracle PL/SQL Secondary Skill --> Windows, Unix scripts, Agile methodology Experience 6 to 9 years JD: To participate in report server configuration / upgrade and other SDLC activitiesincluding testing , deployment and support To be able to write new BO reports or modify existing BO report and also work along with other developers To manage the testing team for unit testing, system testing, integrated testing, UAT etc., To write the technical specification, functional specification, test plans and test scripts To coordinate with other team like Business solution team, source management team, infrastructure support, data centre, production support and others To support production issues and join the incident resolution team during system break down incidents The required skills: Must have Should have been a programmer in BO / Crystal reports and have participated in development life cycle Must have worked on in BO universe and other BO tools Must have created and configured reports Nice to have Exposure to Banking business and Oracle Development experience in .NET or Java Development experience in Oracle - PL/SQL Exposure or work experience in MQ Knowledge of Unix shell scripting Knowledge of windows server management Soft Skills must have Should have good communication Should be a team player and exposure to people management skills Minimum 6+ years of experience

Roles and Responsibilities Prepare dossiers for regulatory submissions, including variations, renewals, and rejections. Review DMFs, CMCs, USDMFs, ASMFs, EDQMs, LOAs, QMS documents for accuracy and compliance with regulations. Coordinate with internal teams to gather necessary information for regulatory submissions. Ensure timely submission of applications to relevant authorities in various markets (US, Europe). Maintain records of all submitted documents and follow up on their status.

Experience Level: 4 to 6 Years Qualification: B.E., Electrical / E&TC Work Location: Pune Notice Period: 30 days Candidate should have experience in development of electronics components like PCB, Cell Module controller (CMC) and High voltage/ Low Voltage connectors. I have attached JD for your reference. Job Description: Roles & Responsibilities: Development of Cell module electronic components like connectors, Cell module controller etc. Voltage, Current, Resistance calculations for development of busbars and HV components. Electric layout design of the cell module. Coordination with the supplier and cross functional teams for development of electronic connectors. Clearance and creepage calculation of Cell module. Component level test planning preparation. Additional Skills: Good Knowhow of Battery pack components and eMobility system. Knowhow of design guidelines for designing HV system. Good to have knowledge of CATIA V5 3D designing of the parts and 2D. Good to have experience in OAS (Open Architecture System) and its integration into design process. Problem-solving skills. Teamwork and communication skills, as design projects are often interdisciplinary. Good knowhow of electronic components and electric circuits is must. Good analytical skills required. Autocrear tool know how is additional advantage.

Christian Medical College is looking for Project Co ?? Ordinator / Junior Research Fellow / Senior Research Fellow for the Department of Clinical Haematology (Job Code-1603 ) to join our dynamic team and embark on a rewarding career journey Research Support: JRFs work under the guidance of senior researchers or principal investigators on research projects They assist in conducting experiments, data collection, literature reviews, and data analysis Data Collection and Analysis: Collecting and recording data from experiments or research studies and using appropriate software or statistical tools for data analysis Literature Review: Conducting comprehensive literature reviews to understand the current state of research in the field and to inform the research design and methodology Experimental Work: Depending on the field, JRFs may perform laboratory experiments, fieldwork, surveys, or other research activities specific to their project Documentation: Keeping detailed records of research procedures, findings, and outcomes This documentation is critical for the research process and for publishing research results Research Proposal Writing: Assisting in the preparation of research proposals and grant applications to secure funding for research projects

Veeva Vault RIMS L2 Support having 3-5 years of experience in RIMS. Veeva certification will be added advantage. The resource may have to work in CET timezone for initial few months. Client interview will be held post initial selection.

Job Summary Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals. Area Of Responsibility 1. New submissions: a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy. 2. Approval : Review & prepare response to deficiency enabling approval of products filed to regulatory agency. 3. Lifecycle management for drug formulations: a. Prepare and review variation , Annual notification and labelling approval for US and OAM b. Review of change control and file variation as per country requirement 4. Regulatory compliance: a. eCTD compilation b. Ensure reposition of comprehensive product information into central repository C. Review regulatory filing impact of variations, change controls, etc.

Role & responsibilities Please find your responsibilities and job description as under: 1. Handling Purchasing of Services (e.g. AMC/CMC, Calibration of Equipment & PT Participation) and Supplies (e.g. Lab Equipment, Chemical & Consumables). 2. Handling purchasing of Capex requirements. 3. Planning and budgeting of purchase functions, involving cost estimation, contract negotiations. 4. Collecting Data for Monthly requirements from all departments (including chemicals, Glassware, stationary and all related things required in lab), merging all data, taking approval. 5. Managing and coordinating for lab Purchase including chemical, glassware and for any other lab related activities 6. Follow ups from vendor for the delivery of requirements. 7. Timely clearance of payments & handling vendor inquiries. 8. Creating PO and process invoice of vendors in EMS module. 9. Responsible for purchase, quotations, sampling, sample registration, reporting & invoicing. 10. Managing sample registration team and guiding them in case of any issues. 11. Supervising reporting team for timely report delivery with zero error. 12. Organizing runners for collection of samples (s) as per clients requirement. 13. Sample receiving, sample booking, and sample distribution to respective departments, Preparation of Quotation, report & invoice, when required and maintaining TAT sheet. 14. Interact with customers to provide information in response to inquiries about services. 15. Daily update of Booking, reporting, Invoice and maintain Food daily matrices on daily basis. 16. Maintain 5 X 5 Data on monthly basis. 17. Operation Based Sales. 18. Other works allotted time to time as when required.

Find a Career With Purpose at Teva Keyword Location Select how often (in days) to receive an alert: Regulatory Affairs Associate III- RA CMC Lifecycle EMSO APAC Date: Jun 18, 2025 Location: Navi Mumbai, India, 400706 Company: Teva Pharmaceuticals Job Id: 62484 Who we are How you ll spend your day Assessment of change controls for registration impact and implementation of all necessary dossier changes; specifically for Europe and International Market. Responsible for compilation of the variations, renewals, RFI responses for the products in the product portfolio in collaboration with other stakeholders. Responsible to keep trackers and database up to date. Briefing the regulatory status in different forums associated with cross functional teams. Experienced in managing software related to Regulatory Affairs and QMS. Your experience and qualifications Academic Degree/PG and thinking level with a chemical/pharmaceutical background. 6+ years of experience in CMC Regulatory Affairs; Europe and International Market preferred. Knowledge on EU registration procedures and pharmaceutical regulations. Good communication skills (written and oral). Interest and capability to work with different software, including Document Management Systems. Accurate, able to prioritize and work according to agreed timelines. Working independently with a moderate level of guidance and direction. Solve complex problems using existing solutions and support. Identify & implement process improvements. Team player Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Description. Sr Regulatory Consultant (Biologics/Biosimilars). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Job Responsibilities. Primary Skills required. Responsible for authoring and review of CMC sections of regulatory submissions, including Modules 2 and 3, for INDs, IMPDs, CTAs, BLAs, and MAAs, as well as briefing packages and health authority responses.. Developing, reviewing, and ensuring the completeness of CMC sections within IND and IMPD applications.. Ensure all documents are authored in accordance with regulatory guidance (FDA, EMA, ICH).. Good understanding of analytical method development, validation, comparability and biosimilarity assessments, upstream and downstream process development.. Provide peer review and mentorship to junior writers or team members, ensuring consistency and scientific accuracy across deliverables.. Experience with post-approval changes, tech transfers, and product lifecycle management.. Excellent written communication, scientific writing, and document organization skills.. Stay current with evolving regulatory expectations and industry best practices related to CMC submissions for biologics and biosimilars.. Secondary Skills Required. Deep understanding of CMC regulatory requirements for biologics/biosimilars, including ICH and region-specific guidance.. Experience with biosimilars, monoclonal antibodies, recombinant proteins, or other biologics.. Qualifications. Minimum 8 years of experience required for CMC-Biologics along with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences.. Ability to work independently and manage multiple priorities in a fast-paced consulting environment.. Detail-oriented, strong organizational skills to manage multiple priorities in a deadline-driven environment. Experience with RIMS/Veeva Vault for submission management, document lifecycle tracking, and regulatory compliance. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

Senior Demonstrator (NM) for the Department of Immuno Hematology and Blood Transfusion Qualification: M.Sc. in Medical Lab Technology Experience: Candidates applying for Senior Demonstrator (NM) post should have completed 4 years as Demonstrator (NM) in CMC. Coordinate the BSc MLT course and also provide laboratory diagnostic services. Job Preference: Worked as AHS Course Coordinator for a minimum of 3 years in an academic institution. Salary: As per institutional Rule Accommodation not Provided 21/06/2025

Sona BLW Precision Forgings Limited Job Description JD Code QTY12 Department Quality Designation Engineer / Sr. Engineer Reports to DGM In Process Quality Qualification BE (Mech/EEE) Preferred industry Automotive Industries Experience 5-8 years Location Chennai JOB DESCRIPTION Job Purpose: In-process Quality Key Accountabilities / Responsibilities: Do process Audit Basic understanding of Processes Verification for APQP and PPAP elements Interpretation of Drawing and ES. Problem solving using 8D Perform DOE to understand variation, and resolve dispute. Documentation to confirm to TS 16949 Handling of measuring instruments, and use of first principle measurement techniques. Effective written and oral communication. SCR, CMC verification Long term and short term process capability study. Key Performance Indicators: Audit Compliance Internal Audit/ External Audit/Customer Audit. Internal and external Audit - Coordination TS documents in line with Current Practice, Updation of documents in line with Customer specific requirements. Driving for Improvements in the Process/Product Rejection reduction project through problem solving Techniques. Person/Competency Specification Essential:Desirable:Knowledge: Basic knowledge on Analytical Tools Basic knowledge on Quality concepts Knowledge on Quality Tools Personal SkillsAttributes: Good attitude to learn Dynamic / go getter Good communication skills Group work culture Key Functional Competencies: Capable of doing product, Process Audits Key Leadership Standards: Team member to participate in small group activities. Follow systems and be predictable Participate in other activities apart from regular work. Form NumberHR-FR-23Revision Number01OriginatorHRRevision Date27- Mar23

Key Responsibilities: Preparing and submission of Sterile Finished Product application CT-10, CT-12, CT-16, CT-21, Form-30, Free sale certificate, Certificate of Pharmaceutical Product, WHO-GMP. Endorsement of Sterile product under the manufacturing licence. Licensing to State drug controller & for getting the licence within a time period given by management. Submission of IND & NDA application of biological products (Cell lines/Tissue Engineered products) Compilation & review of Dossier according to CTD Modules (Module -1,2,3,4 and 5). Review the CMC documents of new product development. Compilation and review of Medical device(s)- Device Master Files. Preparation of the dossier as per checklist of CDSCO MD Rules 2017. Submission of WholeSale & Retails Licence. Labelling and Implementation of Medical Devices, Drug product, Biological product & Cosmetics products. Requirements: Education: Bachelors/Masters degree in Pharmacy, Life Sciences, or a related field. Experience: 3-5 years in Regulatory Affairs within the pharmaceutical, biologics, or medical device industry. Skills: Knowledge of CDSCO, WHO-GMP, and CTD guidelines, experience in dossier preparation & regulatory submissions, strong coordination skills, and understanding of Medical Device Rules 2017. Important Note: "For the first 6 months, the training will be at the Head Office located in Chennai. Travel expenses and accommodation will be provided by the company." Contact us; Siva - 7826802077 Email Id - azaruddin.a@lifecell.in sivaprasad.m@lifecell.in

Responsible for developing and implementing CMC regulatory strategies for assigned products in accordance with global regulations and guidances; and is responsible for the preparation and submission of CMC dossiers for pipeline and commercial products. Accountable for the delivery of all regulatory milestones for moderate to less complex projects through the product lifecycle including assessment of the probability of regulatory success together with risk mitigation measures. Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for smaller-scoped projects. Lead execution of CMC documentation including IND/CTA, NDA/BLA/MAA, postapproval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems. Experience in reviewing scientific information and assessing whether technical arguments are clearly presented, and conclusions are adequately supported by data. Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills. Demonstrated understanding of related fields (e.g., manufacturing, analytical, quality assurance). Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders. Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. Demonstrated effective leadership, communication, and interpersonal skills. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Required Skills: Adaptability, Adaptability, Business Processes, Communication, Communication Management, Detail-Oriented, Document Coordination, Electronic Common Technical Document (eCTD), Employee Training Programs, Financial Statements, Interpersonal Relationships, Management Process, Manufacturing, Mentorship, Project Management, Regulatory Affairs Compliance, Regulatory CMC, Regulatory Communications, Regulatory Compliance Audits, Regulatory Interpretation, Regulatory Research, Regulatory Strategies, Regulatory Strategy Development, Regulatory Submissions, Risk Management and Mitigation {+ 4 more} Preferred Skills: Job Posting End Date: 06/13/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.