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1.0 - 5.0 years
3 - 6 Lacs
Hyderabad
Work from Office
Knowledge on Regulatory guidelines for API & Finished product registration. Preparation, Review and submission of Technical documents/Dossiers (CTD/ACTD) for Regulatory and Non Regulatory Markets. Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling of customer and MOH queries. Coordination with cross-functional teams & Reviewing of Documents (Specification, MOA, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge on EAEU, ICH and EMEA guidelines. Re-registration (Renewal) procedures. Should have hand on experience in handling ODLS, FSSAI, Sugam Portal for Licensing of Drug & Food Products. Prior knowledge on Administrative document applications (COPP, GMP, Free sale and Import License). Registration information management system updates on regular basis. Requirements Bachelors/Masters degree in Biotechnology/ Microbiology/ Pharmacy/ Regulatory Affairs. 1-4 Years of experience as Regulatory Affairs Executive in Pharmaceuticals. Interpersonal and communication skills Planning and organizing skills
Posted 2 weeks ago
10.0 - 20.0 years
13 - 17 Lacs
Bengaluru
Work from Office
About Us Tata Consulting Engineers Limited (TCE) is the largest Indian private sector engineering and project consultancy and an emerging global leader in integrated engineering solutions. With more than 60 years of engineering excellence, TCE has a presence in over 64 countries and over 12000 completed projects, the company operates in 3 core Industry segments -Infrastructure (Water, Environment, Urban Development, Buildings, Manufacturing Facilities, Ports and Harbours, Transportation), Power (Thermal, Hydro, Nuclear, Renewable, Transmission and Distribution) and Resources - Hydrocarbons and Chemicals (Oil, Gas and Refineries, Chemicals, Petrochemicals, Fertilizers, Speciality Chemicals, Pulp and Paper, Cement, Food, Pharmaceuticals and Beverages, Tyre, Glass) as well as Mining and Metallurgy (Mining, Geology, Beneficiation, Steel, Non-ferrous). TCE serves domestic as well as international markets and is known for several first-of-its-kind projects offering Engineering Studies, Design Engineering Services, Project Management Consultancy Services, OPEX and IIOT across all three verticals. A part of Tata Group - India’s most respected group, TCE is a 100 percent subsidiary of Tata Sons Limited Design your Future with us At TCE, you will experience a supportive environment that empowers you to excel, whether you are based in our offices or at a client site. We embrace diversity, equity, and inclusion, fostering a workplace where every individual can thrive by contributing their unique skills and perspectives to deliver exceptional results for our clients. Our comprehensive compensation and benefits packages are designed to meet the diverse needs of our employees and their families, complemented by a robust global well-being program. As a leading global infrastructure firm, we are committed to your growth and success, offering access to cutting-edge technology and impactful projects that offer flexibility and significant professional opportunities. Join us and become part of a global company that values your potential and supports your career development. Purpose & Scope of Position The Project Engineer (PE) will be part of an engineering stream providing engineering services to large and small projects. The PE provides support to the Project Manager (PM) and Engineering Manager (EM) and is responsible for supervising a team of working engineer and designers. The PE provides leadership and assists in the resolution of all technical issues related to the discipline. Experience • 10+ years of experience in relevant design discipline • Experience in engineering and package coordination Qualification • Postgraduate or graduate in an engineering discipline • Registration as a professional engineer with the governing authority (preferable) Key Responsibilities 1. Assist the PM and EM with the delivery of project requirements as they relate to scope, quantities, cost and schedule 2. Prepare Engineering Work Packages (EWPs) in consultation with the Engineering Manager 3. Assist in the compilation and delivery of monthly engineering status reports 4. Participate in and contribute to design reviews 5. Represent the discipline in the project engineering coordination meetings 6. Prepare and/or review project procedures, standard specifications and design criteria 7. Review and evaluate technical work prepared by junior engineers, intermediate engineers, designers, technicians and technologists 8. Ensure relevant technical experts are involved in the design process as required and facilitate the sharing of technical expertise across projects 9. Perform conceptual and detailed engineering design 10. Prepare engineering work (calculations, reports, specifications, evaluations, recommendations etc.) where required 11. Provide and/or coordinate training for resources assigned to the project 12. Work to ensure the implementation of safety in design 13. Ensures measurement of progress on all contracts for reporting and progress claim purposes. 14. Responsible to ensure timely availability of discipline data to other disciplines, and work with fellow PEs and EM on integration of the same and resolution of any issues and challenges 15. Document value additions and best practices and ensure communication of the same to fellow project engineers of other projects and discipline leadership 16. Support technology team/ Project team for development and automation works as required. 17. Ensure compliance to all quality and document management processes within TCE and as agreed with customer. 18. Manage performance data of reportees and provide periodic feedback. 19. Provides resource loading forecast to TL. 20. Keeps records of learning’s during the project and provides inputs to PM during job closure report. 21. Prepare technical specifications/ bid evaluation/ technical recommendation where required 22. Interact with the discipline engineers of customer during entire life cycle of the project and beyond. Competencies Action Oriented Manages Complexity Technical Knowledge Quantity of Work Knowledge
Posted 2 weeks ago
2.0 - 7.0 years
1 - 6 Lacs
Ankleshwar
Work from Office
Preparation of Technical documents like below: COA/ Certificate of Analysis Specifications/ TDS Method of Analysis Stability Data DMF/ Drug Master File Declarations Preparation of Vendor Questionnaire Customer response for technical queries
Posted 3 weeks ago
3 - 7 years
5 - 12 Lacs
Bengaluru
Work from Office
Role & responsibilities 1. Expertise in Companies Act, 2013 and miniating of secretarial records. 2. Knowledge of compliances under Listing Regulations. 3. Preparation of Annual Reports of listed, Public & Private company. 4. Drafting of Agenda and Scheduling of Board Meetings 5. Drafting LLP Agreements and various other agreements. 6. Filing of forms with Ministry of Corporate Affairs 7. Co-ordination with Registrar of Companies, Registrar and Transfer Agent, Depositories, etc. 8. Preparing minutes of Board Meeting, Shareholders meeting, Debenture Holders meeting & various Committee meetings. 9. RBI filings 10. Documentation for Merger & De-merger 11. Documentation for Allotment of Equity shares, Preference shares & various types of Debentures, including buyback & redemptions. 12. Incorporation of New Companies, LLPs 13. Conversion of Company to LLP and LLP to Company. 14. Drafting of various documents – Board’s Report, Resolutions, etc 15. Knowledge of various kind of corporate actions. 16. Conducting of Secretarial Audit.
Posted 2 months ago
3 - 8 years
5 - 10 Lacs
Bengaluru
Work from Office
Our brand new FinTech business unit with teams in Amsterdam, Shanghai and Bangalore develops new products and drives innovation to help us continue removing financial friction from the travel process. That makes buying and selling travel-related products and services simpler for both travelers and partners. The financial Systems team in the FinTech business unit provides technical expertise to the finance department and is responsible for supporting SAP ERP/S4HANA, SAP BI, Native HANA solutions, and many other connected external systems. We want to change the way people work with enterprise systems, by building an application platform that supports simplification of business processes and empowers the finance community with better integrations and financial insights. This role is focused on make sure we develop Integration solutions for Booking Financial services and our different Business units and Brands. Key Job Responsibilities and Duties Help our team with providing best practices, enterprise architecture standards, and reusable integration patterns. Ability to take fast decisions in a very dynamic environment, with some level of uncertainty Driving and leading architecture design discussions and actively documenting them. Build template solutions on complex integration cases and liaise with our business stakeholders and traduce their business needs into Integration solutions. Maintaining and supporting existing integration interfaces. Create technical design and actual implementation of solutions. Continuously monitor and propose improvements and innovations in our integration landscape The quality, reusability and proficiency of all above aspects conforms the KPIs of this role Role Qualifications and Requirements Min 3+ years of experience in the IT industry having 1+ full implementation cycle in integration area. Good understanding of concepts such as Mulesoft, EDA, MOA, SOA, SOAP, REST APIs, RESTful, RPC/RFC, event streams such as Kafka and different integration patterns. Integration platform experience with Mule 4.x, CloudHub 1.0, (Ideally some experience on CloudHub 2.0, not essential) as well as strong development experience preferable with JAVA/J2EE and build tools like Maven, other integration platform experience, especially event driven integration, SAP CM, CPI is a plus.. Exposure to a variety of enterprise architectures from a large monolithic architecture to hybrid landscapes consisting of distributed systems and microservices and event-driven architectures. Experience of API led design using RAML/OAS and experience of supporting APIs through the full API lifecycle and system observability is a plus (Graphite, Grafana etc.) Strong analytical and problem-solving skills as well as good communication skills while being organized, flexible, proactive, and result-oriented.
Posted 2 months ago
5 - 7 years
5 - 8 Lacs
Vadodara
Work from Office
Role & responsibilities Preferred candidate profile 1. Responsible for the Change control Handling through Track wise related to Spec & STP & CAPA 2. Prepare the Specification & Standard testing procedure of API Site. 3. Review of Method of analysis (MOA), Specification, STP of RM, IM, PM, INP, API & Cleaning generated by R&D Analytical. 4. Review of Standard qualification COA. 5. Review of Method comparison & MOA with Pre-validation data 6. Review of Validation Protocol & validation Report with respect to analytical data and Journal. 7. Review of R&D batches Stability data. 8. Issuance, login and closing of Incidence and change control of DQA/R&D-synthesis/R&D-Analytical. 9. Issuance of format, Logbooks, BMR and uncontrolled copy of MOA and/or Spec & STP. 10. Document and data control i.e. Receiving, Issuance/Distribution, Archival, Control, Storage and destruction of documents. 11. Assigning analytical method validation protocol and Report Numbering. 12. Responsible for sample management activity (i.e. Receiving, Issuance and Discard)
Posted 2 months ago
1 - 3 years
3 - 5 Lacs
Mumbai
Work from Office
Filling of various forms with ROC & compliance as required. -Preparation of Minutes and various registers as required by Companies Act, 2013. - Incorporation of Company/ LLP. -Strike off of Company/ LLP. -Annual Compliance of the company. -Alteration of MOA, AOA or any LLP Agreement. -Increase in Authorised share capital. -Allotment of shares through private placement/ Rights Issue/ Bonus Issue/ ESOP Etc.
Posted 2 months ago
12 - 15 years
14 - 15 Lacs
Ankleshwar
Work from Office
collaborates with the Quality Control (QC) team to ensure that laboratory testing is conducted appropriately and meets the required specifications. Ensure that all necessary documentation is completed accurately Call: 91-9327657730 / 9724346949 Required Candidate profile Nitrosamine Impurity, Elemental impurity, Genotoxic Impurity & their role related DMF Filing. Preparation & review (MOA), standard testing procedure (STP) and other documents related to QC.
Posted 3 months ago
4 - 6 years
6 - 8 Lacs
Bengaluru
Work from Office
We have opening for below mention profile / Role 1. Qualified Company Secretary 2. Semi Qualified Company Secretary 3. Articleship - CS We are seeking a highly qualified and experienced Company Secretary with over 4 years of experience in corporate governance, compliance, and legal documentation. The ideal candidate should have extensive knowledge of drafting, reviewing, and negotiating agreements and be adept at ensuring compliance with statutory and regulatory requirements. Key Responsibilities : Corporate Governance : Ensure the company complies with all applicable laws, regulations, and internal policies. Board Meetings & Documentation : Organize board meetings, prepare agendas, draft minutes, and maintain statutory records. Legal Documentation : Draft, review, and negotiate a wide range of agreements, including shareholder agreements, service agreements, NDAs, MOUs, and other legal documents. Regulatory Compliance : Ensure timely compliance under Companies Act and FEMA Advisory Role : Provide strategic legal advice to the board and senior management on various legal matters, including mergers, acquisitions, and joint ventures. Stakeholder Communication : Act as the primary point of contact between the board, shareholders, and regulatory authorities. Qualifications & Skills : Qualified Company Secretary (CS) with membership in the Institute of Company Secretaries of [Country]. Minimum of 5 years of experience in a similar role, preferably within a corporate or legal environment. Proven experience in drafting, reviewing, and negotiating a variety of legal agreements. Strong understanding of corporate governance, compliance, and regulatory frameworks. Excellent communication, interpersonal, and organizational skills
Posted 3 months ago
1 - 2 years
5 - 11 Lacs
Mumbai Suburbs, Mumbai
Work from Office
Online Application for FASSAI License, PAN & TAN, Import Export Code, Shop Establishment license, MSME Registration, professional tax Registration, Startup Registration Preparation,Drafting of various resolutions,explanatory statements,notice, agenda Required Candidate profile Incorporation of all types of companies i.e. Private, Public, One Person Company, Section-8 Company, Producer Company, Government Companies and LLP Organizing Board Meetings, ensuring compliance
Posted 3 months ago
5 - 8 years
7 - 10 Lacs
Bengaluru
Work from Office
The financial Systems team in the FinTech business unit provides technical expertise to the finance department and is responsible for supporting SAP ERP/S4HANA, SAP BI, Native HANA solutions, and many other connected external systems. We want to change the way people work with enterprise systems, by building an application platform that supports simplification of business processes and empowers the finance community with better integrations and financial insights. This role is focused on make sure we develop Integration solutions for Booking Financial services and our different Business units and Brands. Key Job Responsibilities and Duties Help our team with providing best practices, enterprise architecture standards, and reusable integration patterns. Ability to take fast decisions in a very dynamic environment, with some level of uncertainty Driving and leading architecture design discussions and actively documenting them. Build template solutions on complex integration cases and liaise with our business stakeholders and traduce their business needs into Integration solutions. Maintaining and supporting existing integration interfaces. Create technical design and actual implementation of solutions. Continuously monitor and propose improvements and innovations in our integration landscape The quality, reusability and proficiency of all above aspects conforms the KPIs of this role Role Qualifications and Requirements Min 5+ years of experience in the IT industry having 2+ full implementation cycle in integration area. Good understanding of concepts such as Mulesoft, EDA, MOA, SOA, SOAP, REST APIs, RESTful, RPC/RFC, event streams such as Kafka and different integration patterns. Integration platform experience with Mule 4.x, CloudHub 1.0, (Ideally some experience on CloudHub 2.0, not essential) as well as strong development experience preferable with JAVA/J2EE and build tools like Maven, other integration platform experience, especially event driven integration, SAP CM, CPI is a plus.. Exposure to a variety of enterprise architectures from a large monolithic architecture to hybrid landscapes consisting of distributed systems and microservices and event-driven architectures. Experience of API led design using RAML/OAS and experience of supporting APIs through the full API lifecycle and system observability is a plus (Graphite, Grafana etc.) Strong analytical and problem-solving skills as well as good communication skills while being organized, flexible, proactive, and result-oriented. Pre-Employment Screening If your application is successful, your personal data may be used for a pre-employment screening check by a third party as permitted by applicable law. Depending on the vacancy and applicable law, a pre-employment screening may include employment history, education and other information (such as media information) that may be necessary for determining your qualifications and suitability for the position.
Posted 1 month ago
3 - 8 years
5 - 10 Lacs
Bengaluru
Work from Office
Our brand new FinTech business unit with teams in Amsterdam, Shanghai and Bangalore develops new products and drives innovation to help us continue removing financial friction from the travel process. That makes buying and selling travel-related products and services simpler for both travelers and partners. The financial Systems team in the FinTech business unit provides technical expertise to the finance department and is responsible for supporting SAP ERP/S4HANA, SAP BI, Native HANA solutions, and many other connected external systems. We want to change the way people work with enterprise systems, by building an application platform that supports simplification of business processes and empowers the finance community with better integrations and financial insights. This role is focused on make sure we develop Integration solutions for Booking Financial services and our different Business units and Brands. Key Job Responsibilities and Duties Help our team with providing best practices, enterprise architecture standards, and reusable integration patterns. Ability to take fast decisions in a very dynamic environment, with some level of uncertainty Driving and leading architecture design discussions and actively documenting them. Build template solutions on complex integration cases and liaise with our business stakeholders and traduce their business needs into Integration solutions. Maintaining and supporting existing integration interfaces. Create technical design and actual implementation of solutions. Continuously monitor and propose improvements and innovations in our integration landscape The quality, reusability and proficiency of all above aspects conforms the KPIs of this role Role Qualifications and Requirements Min 3+ years of experience in the IT industry having 1+ full implementation cycle in integration area. Good understanding of concepts such as Mulesoft, EDA, MOA, SOA, SOAP, REST APIs, RESTful, RPC/RFC, event streams such as Kafka and different integration patterns. Integration platform experience with Mule 4.x, CloudHub 1.0, (Ideally some experience on CloudHub 2.0, not essential) as well as strong development experience preferable with JAVA/J2EE and build tools like Maven, other integration platform experience, especially event driven integration, SAP CM, CPI is a plus.. Exposure to a variety of enterprise architectures from a large monolithic architecture to hybrid landscapes consisting of distributed systems and microservices and event-driven architectures. Experience of API led design using RAML/OAS and experience of supporting APIs through the full API lifecycle and system observability is a plus (Graphite, Grafana etc.) Strong analytical and problem-solving skills as well as good communication skills while being organized, flexible, proactive, and result-oriented.
Posted 1 month ago
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