Makro Group

Sr.Dot Net Developer -Lead In-Office Hyderabad, Telangana, India Sr. Dot Net Developer (Sr .Full Stack Dot Net developer) Hyderabad, India DDi, a MakroGroup company https:www.ddismart.com, is an innovative Technology partner for BioPharma and Medical Device companies. With a unique blend of functional and domain expertise, DDi serves the technology needs of the Clinical, Regulatory, and Enterprise domains in the industry. DDi provides innovative technology products and automation solutions to companies of various sizes. Role and Responsibilities: As a Sr. Dot Net Developer at DDi, you will be responsible for: Development of Microsoft .NET 4.x applications using C Utilizing core Microsoft .Net technologies including WCF and EF Working with web development technologies such as ASP.NET, MVC3, JavaScript, AJAX, and CSS Experience in Oracle or SQL server or both Knowledge on Mongo DB is an added advantage Debugging, performance profiling, and optimization Understanding and applying object oriented and service oriented application development techniques Working both independently and in a team environment Excellent oral, presentation, and written communication skills Candidate Qualifications: To be eligible for this position, you should have: Education in BE/B. Tech/MCA/M Tech 5-8 years of experience in the IT industry Required Skills: Proficient in Microsoft .NET 4.x development using C Good knowledge and experience with core Microsoft .Net technologies including WCF and EF Experience with web development technologies including ASP.NET, MVC3, JavaScript, AJAX, and CSS,Angular /Angular Js is preferred

QUALITY ASSURANCE & VALIDATION Responsible for development, implementation, and effectiveness of quality strategies, programs and functions for all products and technical solutions to meet all corporate and regulatory objectives with respect to quality initiatives. Summary: Plans, coordinates and directs activities concerned with DDi QMS, Quality manual, compliance related activities (ICH, 21 CFR, GPDR etc), SOP management, and regulatory compliance of processes and products. Plans and coordinates the quality management program designed to ensure quality development of products consistent with established standards. Accountabilities Interfaces with customers and vendors representing company as Quality champion. Formulates and maintains quality assurance objectives complementary to corporate policies and goals. Designs and implements quality assurance training programs to key personnel in conjunction with managers. Prepares and maintains control plans and revises/audits processes, responds to customers quality concerns. Manage client and regulatory authority audits Maintains companywide Quality Management System and ISO 9001, 27001 and ISO 14155 compliance. Oversee and own SOPs for entire organization Author or Review validation documentation (plans, protocols, test suites, reports, etc.). Contributes to project discoveries, project kickoffs, review proposals and statements of work to ensure CSV standards are represented. Coordinates client specific validation activities with practice leads. Enforce QA requirements for IT quality systems with potential GxP impact. Support GxP decisions/strategies during validation projects. Document applicable deviations and documentation anomalies for computer systems undergoing validation. Provides leadership throughout the lifecycle of a project, guiding the understanding of the validation process that the project team has through design, development, and implementation to ensure project requirements are met. Review requirements, traceability matrices, test suites and test executions. Travel involved. Other duties as assigned. KRA spread: QMS and corporate Quality management: 60% Validation: 40% Location - Madhapur, Hyderabad, Telangana, India

Role and Responsibilities: As a Sr. Dot Net Developer at DDi, you will be responsible for: Development of Microsoft .NET 4.x applications using C Utilizing core Microsoft .Net technologies including WCF and EF Working with web development technologies such as ASP.NET, MVC3, JavaScript, AJAX, and CSS Experience in Oracle or SQL server or both Knowledge on Mongo DB is an added advantage Debugging, performance profiling, and optimization Understanding and applying object oriented and service oriented application development techniques Working both independently and in a team environment Excellent oral, presentation, and written communication skills Candidate Qualifications: To be eligible for this position, you should have: Education in BE/B. Tech/MCA/M Tech 5-8 years of experience in the IT industry Required Skills: Proficient in Microsoft .NET 4.x development using C Good knowledge and experience with core Microsoft .Net technologies including WCF and EF Experience with web development technologies including ASP.NET, MVC3, JavaScript, AJAX, and CSS,Angular /Angular Js is preferred

Role and Responsibilities: Responsible for developing and maintaining Microsoft .NET applications using C#. Should have a good knowledge and experience with core Microsoft .Net technologies including WCF and EF. Should also have experience with web development technologies such as ASP.NET, MVC3, JavaScript, AJAX, and CSS. Knowledge in either Oracle or SQL server or both will be required. Debugging, performance profiling, and optimization skills are also essential for this role. Knowledge on Angular/ Angular JS is an added advantage . Preferred Angular/Angular JS Candidate Qualifications: The ideal candidate should have an education in BE/B.Tech/MCA/M.Tech with a Computer Science backgro 3-4 years of experience in the IT industry. Required Skills: Microsoft .NET 4.0 C# WCF and EF ASP.NET, MVC3, JavaScript, AJAX, CSS Oracle or SQL server . Angular /Angular JS

Duties and Responsibilities: Determining financial objectives, preparing & implementing systems, policies & procedures and reporting variances to facilitate internal financial control Fosters a strong internal control and compliance environment within the business. Assures adherence to Generally Accepted Accounting Principles in India, Maintain systems and controls for compliant and efficient accounting and financial reporting. Manages Government Accounting Compliance to develop and maintain policies, procedures, and instructions that meet regulatory, banking, and reporting standards. Manages Billing and Accounts Receivable functions ensuring the accurate and timely management of Accounts Receivable aging components including billings. Manages the activities of the Accounts Payable functions to ensure the accurate and timely processing of accounts payable, purchase orders. Manages the activities of the Payroll and Timekeeping functions to ensure the accurate and timely processing of payroll and payroll related tax reporting. Primary liaison with independent / external audits and co-ordination of internal audits. Ensures timely and accurate financial closing and reporting (monthly, quarterly and annual basis). Manages the financial Planning and Analysis function including budgeting, forecasting and reporting to enable timely and appropriate business decisions Handling Treasury function including cash management, liaising with banks/ financial institutions Preparation of MIS reports to provide feedback to top management on financial performance, as per Managements Needs/Requirements. Ensuring monthly closure of books on time, preparation of monthly & yearly P&L and Balance sheet, collating and correct accounting for provisions and monthly review of Schedules All matters related to Income Tax / TDS/ Service tax, Licences, matters related to company law and compliance.

DDi has built its competency with a unique blend of functional / domain expertise to serve the technology needs of this industry we serve Clinical, Regulatory, and Enterprise domains by providing innovative technology products and automation solutions for companies of various sizes (Clinical Solutions Regulatory Solutions) Experience: Minimum of 7+years of experience in the Core Product based IT/Software Industry or IT/Software consulting background Education Any UG/PG in the Computer Science background Role and Responsibilities: Position Core Product based IT/Software Industry or IT/Software consulting areas for our Global locations Develop and implement strategy while maintaining relationships and favorable international contacts with new and reactivated customers as well as specifically designated target accounts in the region by preparing and delivering solution presentations Will be responsible for developing and executing business development strategy and plan, both short and long-range, to ensure achievement of company sales targets, growth in profits and expansion of company services Work with marketing and Pre-sales teams effectively for lead generation programs and your services/products positioning with your client base Practice development - build and maintain Service visibility with the relevant client base through 'thought leadership' initiatives like White papers, Webinars and Workshops Accountable for assigned goals and targets Team management - train the team on a range of skills in different areas of projects in the implementation Ability to perform business travel (local/international), up to 25% Requirements: Proven success and 7+ years of experience in Core Product based IT/Software Industry or IT/Software consulting environment Proven experience in International or Global IT/Software projects Great communicator Cooperative style of work as well but also assertive when necessary Ability to capture and explain complex relationships Location - Madhapur, Hyderabad, Telangana, India

Role and Responsibilities: The Lead - Strategic Business Development will play a crucial role in maintaining strong client relationships, handling clients, and acquiring new clients for our Business Development process. They will be responsible for positioning MakroCare's specialized services with strategic planning and implementation for medical devices and diagnostics companies in Europe and the USA. Additionally, the role involves developing and implementing business development strategies, maintaining international contacts, achieving sales targets, and working with the marketing and pre-sales teams for lead generation. Candidate Qualifications: Bachelor's Degree in any Life Science with an MBA/PGDM certification Minimum of 8 - 12 years of experience in the BA BE/CRO industry as a Business Development. Proven success and experience in regulatory projects within the Biotech/Life sciences/pharmaceutical environment Experience in international pharmaceutical projects with excellent communication skills Cooperative and assertive working style with the ability to understand and explain complex relationships Basic knowledge of data fields related to pharmaceutical products Required Skills: Business Development Strategy & Services Client Handling New Client Acquisition HealthCare, Medical Devices, Regulatory Affairs & Clinical Research .

Experience: Minimum of 7+years of experience in the Core Product based IT/Software Industry or IT/Software consulting background Education Any UG/PG in the Computer Science background Role and Responsibilities: Position Core Product based IT/Software Industry or IT/Software consulting areas for our Global locations Develop and implement strategy while maintaining relationships and favorable international contacts with new and reactivated customers as well as specifically designated target accounts in the region by preparing and delivering solution presentations Will be responsible for developing and executing business development strategy and plan, both short and long-range, to ensure achievement of company sales targets, growth in profits and expansion of company services Work with marketing and Pre-sales teams effectively for lead generation programs and your services/products positioning with your client base Practice development - build and maintain Service visibility with the relevant client base through 'thought leadership' initiatives like White papers, Webinars and Workshops Accountable for assigned goals and targets Team management - train the team on a range of skills in different areas of projects in the implementation Ability to perform business travel (local/international), up to 25% Requirements: Proven success and 7+ years of experience in Core Product based IT/Software Industry or IT/Software consulting environment Proven experience in International or Global IT/Software projects Great communicator Cooperative style of work as well but also assertive when necessary Ability to capture and explain complex relationships

Manager - Business Development (Clinical Research)Role and Responsibilities: The Lead - Strategic Business Development will play a crucial role in maintaining strong client relationships, handling clients, and acquiring new clients for our Business Development process. They will be responsible for positioning MakroCare's specialized services with strategic planning and implementation for medical devices and diagnostics companies in Europe and the USA. Additionally, the role involves developing and implementing business development strategies, maintaining international contacts, achieving sales targets, and working with the marketing and pre-sales teams for lead generation. Candidate Qualifications: Bachelor's Degree in any Life Science with an MBA/PGDM certification Minimum of 8 - 12 years of experience in the BA BE/CRO industry as a Business Development. Proven success and experience in regulatory projects within the Biotech/Life sciences/pharmaceutical environment Experience in international pharmaceutical projects with excellent communication skills Cooperative and assertive working style with the ability to understand and explain complex relationships Basic knowledge of data fields related to pharmaceutical products Required Skills: Business Development Strategy & Services Client Handling New Client Acquisition HealthCare, Medical Devices, Regulatory Affairs & Clinical Research Location - Madhapur, Hyderabad, Telangana, India

Role and Responsibilities: Responsible for developing and maintaining Microsoft .NET applications using C#. Should have a good knowledge and experience with core Microsoft .Net technologies including WCF and EF. Should also have experience with web development technologies such as ASP.NET, MVC3, JavaScript, AJAX, and CSS. Knowledge in either Oracle or SQL server or both will be required. Debugging, performance profiling, and optimization skills are also essential for this role. Knowledge on Angular/ Angular JS is an added advantage. Preferred Angular/Angular JS Candidate Qualifications:The ideal candidate should have an education in BE/B.Tech/MCA/M.Tech with a Computer Science backgro3-4 years of experience in the IT industry. Required Skills:Microsoft .NET 4.0C#WCF and EFASP.NET, MVC3, JavaScript, AJAX, CSSOracle or SQL server. Angular /Angular JS Location - Madhapur, Hyderabad, TS, India

Duties and Responsibilities:Determining financial objectives, preparing & implementing systems, policies & procedures and reporting variances to facilitate internal financial controlFosters a strong internal control and compliance environment within the business. Assures adherence to Generally Accepted Accounting Principles in India, Maintain systems and controls for compliant and efficient accounting and financial reporting.Manages Government Accounting Compliance to develop and maintain policies, procedures, and instructions that meet regulatory, banking, and reporting standards.Manages Billing and Accounts Receivable functions ensuring the accurate and timely management of Accounts Receivable aging components including billings.Manages the activities of the Accounts Payable functions to ensure the accurate and timely processing of accounts payable, purchase orders.Manages the activities of the Payroll and Timekeeping functions to ensure the accurate and timely processing of payroll and payroll related tax reporting.Primary liaison with independent / external audits and co-ordination of internal audits.Ensures timely and accurate financial closing and reporting (monthly, quarterly and annual basis).Manages the financial Planning and Analysis function including budgeting, forecasting and reporting to enable timely and appropriate business decisionsHandling Treasury function including cash management, liaising with banks/ financial institutionsPreparation of MIS reports to provide feedback to top management on financial performance, as per Managements Needs/Requirements.Ensuring monthly closure of books on time, preparation of monthly & yearly P&L and Balance sheet, collating and correct accounting for provisions and monthly review of SchedulesAll matters related to Income Tax / TDS/ Service tax, Licences, matters related to company law and compliance

Perform maintenance of company SOPs in compliance with ICH-GCP, international and national regulations Review, approval and archival of company SOPs in compliance with ICH-GCP, international and national regulations Review and maintain company archives of clinical protocols and study documents Conduct QA internal audits of all aspects of the Clinical Research Departments activities to ensure compliance with ICH-GCP and applicable international and company procedures Perform QA reviews of protocols and other documents and data in preparation for submission to IRB/IEC, regulatory health authorities and publications Provide training to research staff on GCP, ICH and local regulations (as required) Generate, maintain and manage documents and training records of the activities of the Clinical Research Department Document Control & Issuance Preparation of Master Index to all QAU files & Documents Filling of all Master documents after approval in a sequential way so that it can be easily identified Skills and Knowledge needed on the following guidelines ICH-GCP ISO9001:2015 ISO14155:2011 ISO13485:2016

Job Roles and Responsibilities: Perform maintenance, review, and approval of company Standard Operating Procedures (SOPs) in compliance with ISO standards and applicable international and national regulations. Prepare and review Quality Management System (QMS) documents, CQA procedures, and assist in reviewing department SOPs as needed. Manage SOPs in mLMS, create users, review training records, and escalate non-compliance issues to the Head of CQA or relevant department heads. Maintain the CQA document repository and archive validation protocols and documents in line with regulatory requirements. Conduct internal audits of Clinical Research Department activities and ISO requirements, ensuring compliance with ICH-GCP and company procedures. Provide training to staff on ISO standards and local regulations when necessary. Control and manage documents, including maintaining master lists and issuing change controls, deviations, CAPAs, amendments, and notes to file. Update logs for change control, deviations, CAPAs, amendments, and NTFs. Prepare annual CQA reports and trend analysis, and assist with external audits from clients, certification bodies, or regulatory authorities. Requirements: Education: Bachelor's or Master's in Life Sciences (or related field). Experience: 2-3 years of experience in Clinical Quality Assurance or related roles. Familiarity with ISO regulations, ICH-GCP guidelines, and QMS. Experience in conducting internal audits and maintaining regulatory documentation. Note: Additional responsibilities may be assigned by the Head of Department (HOD).

Job Title: Senior Regulatory Publishing Specialist Responsibilities: Technical Document Preparation: Lead the preparation, review, and submission of Technical documents/Dossiers (CTD/ACTD) for both Regulatory and Non-Regulatory Markets. eCTD Publishing: Proficiently handle the electronic regulatory submissions (eCTD), ensuring accuracy and compliance with regulatory standards. Submission Build Activities: Execute submission build activities, including creating inter-document links, conducting quality checks, validating compiled submissions, and ensuring timely dispatch. Collaboration with RA - Ops Team: Coordinate and engage with the Regulatory Affairs Operations team to facilitate on-time submissions and publishing tasks. Manufacturing Document Review: Review critical manufacturing documents such as MFC, BMR, process validation Protocol/report, stability protocol/report, sampling protocol, process validation protocol, and PDR. Response to Agency's Queries: Prepare and review responses to regulatory agencies' queries, ensuring timely submission within stipulated deadlines. Regulatory Submissions Development: Develop and deliver comprehensive regulatory submissions within agreed-upon timeframes, providing crucial regulatory support to project teams for assigned projects. Qualifications: Education: Bachelor's/Master's Degree (preferably in B Pharm/ M Pharm) or Any Life Science field. Experience: Minimum 3-6 years of hands-on experience within the CRO/Biotech/ Biopharma industry. Expertise: Demonstrated expertise in gap analysis, publishing, and knowledge of CTD compilation. Communication Skills: Excellent communication and interpersonal skills, both written and spoken, with the ability to effectively interact with sponsors and internal stakeholders at all levels.

Role and Responsibilities:As a Senior Research Analyst (Secondary Research) at MakroCare, your role will involve performing comprehensive secondary research to provide detailed information and complete profiles of products You will be responsible for capturing data on companies developing drugs, devices, and other pharmaceutical products from various sources such as press releases, annual reports, clinical trial reports, and more Your primary Responsibilities will include:Grasping new concepts quickly and evaluating scientific data Literature - review, Drug, Medical Devices, Regulatory search and ClinicalTrials review & secondary searchKeeping up-to-date with changes in regulatory legislation and guidelines Conducting intelligence research and analysis on public, biotech, and pharma companies Compiling and analyzing data using modern and traditional methodsEvaluating applicable laws and regulations to determine impactMentoring team members in data research and analysis Candidate Qualifications:To be eligible for this role, you should meet the following criteria:4-6 years of experience in (Drug, Clinical Trials & Med Devices) - Literature, Regulatory, Clinical Trials data research and data analysis Education in any UG/PG in Life SciencesGood knowledge and skills in Scientific terminology, Secondary research and Regulatory Authorities (likely Drug, Clinical Trials & Medical Devices) Required Skills:This role requires the following skills:Drug, Regulatory Secondary Data Research and Clinical Trials Secondary Data Research Good knowledge of all aspects of product development, including research, Drugs, Medical devices, Regulatory Affairs, Clinical trials, manufacturing practices, regulations, and approval processesLiterature Search and Secondary Research skills Knowledge of drugs, Medical Devices and clinical trials Location - Madhapur, Hyderabad, Telangana, India

Duties and Responsibilities: Determining financial objectives, preparing & implementing systems, policies & procedures and reporting variances to facilitate internal financial control Fosters a strong internal control and compliance environment within the business. Assures adherence to Generally Accepted Accounting Principles in India, Maintain systems and controls for compliant and efficient accounting and financial reporting. Manages Government Accounting Compliance to develop and maintain policies, procedures, and instructions that meet regulatory, banking, and reporting standards. Manages Billing and Accounts Receivable functions ensuring the accurate and timely management of Accounts Receivable aging components including billings. Manages the activities of the Accounts Payable functions to ensure the accurate and timely processing of accounts payable, purchase orders. Manages the activities of the Payroll and Timekeeping functions to ensure the accurate and timely processing of payroll and payroll related tax reporting. Primary liaison with independent / external audits and co-ordination of internal audits. Ensures timely and accurate financial closing and reporting (monthly, quarterly and annual basis). Manages the financial Planning and Analysis function including budgeting, forecasting and reporting to enable timely and appropriate business decisions Handling Treasury function including cash management, liaising with banks/ financial institutions Preparation of MIS reports to provide feedback to top management on financial performance, as per Managements Needs/Requirements. Ensuring monthly closure of books on time, preparation of monthly & yearly P&L and Balance sheet, collating and correct accounting for provisions and monthly review of Schedules All matters related to Income Tax / TDS/ Service tax, Licences, matters related to company law and compliance Location- Hyderabad,Madhapur, TS

Dot Net Developer (Jr) Role and Responsibilities: Responsible for developing and maintaining Microsoft NET applications using C# Should have a good knowledge and experience with core Microsoft Net technologies including WCF and EF Should also have experience with web development technologies such as ASP NET, MVC3, JavaScript, AJAX, and CSS Knowledge in either Oracle or SQL server or both will be required Debugging, performance profiling, and optimization skills are also essential for this role Knowledge on Angular/ Angular JS is an added advantage Preferred Angular/Angular JS Candidate Qualifications: The ideal candidate should have an education in BE/B Tech/MCA/M Tech with a Computer Science backgro3-4 years of experience in the IT industry Required Skills:Microsoft NET 4 0C#WCF and EFASP NET, MVC3, JavaScript, AJAX, CSS Oracle or SQL server Angular /Angular JS

Role and Responsibilities: Position Core Product based IT/Software Industry or IT/Software consulting areas for our Global locations. Develop and implement strategy while maintaining relationships and favorable international contacts with new and reactivated customers as well as specifically designated target accounts in the region by preparing and delivering solution presentations. Will be responsible for developing and executing business development strategy and plan, both short and long-range, to ensure achievement of company sales targets, growth in profits and expansion of company services. Work with marketing and Pre-sales teams effectively for lead generation programs and your services/products positioning with your client base Practice development - build and maintain Service visibility with the relevant client base through 'thought leadership' initiatives like White papers, Webinars and Workshops. Accountable for assigned goals and targets Team management - train the team on a range of skills in different areas of projects in the implementation Ability to perform business travel (local/international), up to 25% Requirements: Proven success and 7+ years of experience in Core Product based IT/Software Industry or IT/Software consulting environment. Proven experience in International or Global IT/Software projects Great communicator Cooperative style of work as well but also assertive when necessary Ability to capture and explain complex relationships

Minimum Requirements 7+ year experience as a Sr.UI developer College or University degree in Computer Science or a related discipline B Tech/MCA Core Competency Requirements Excellent communication and teamwork skills Write create clean, effective and unit testable code for simple or complex user tasks Work in different SDLC environments like waterfall, agile, rapid development and prototyping environment where effective communication is paramount Contribute to building a positive, can-do, high-performance culture Ability to work with cross functional technology teams, product management teams and UX teams to drive exceptional user experience Maintain/support existing web/mobile applications Skills: Angular, Bootstrap. Looking mainly into Front End Developer Job Requirement: Excellent Proficiency with JavaScript, CSS3, HTML5, RESTful APIs Strong proficiency with web related protocols and architectures (MVC, MVVM, REST APIs, JSON, HTTP) Experience in working with angular, bootstrap and data visualization libraries Validating user actions on the client side and providing responsive feedback Experience with responsive web design and development, cross browser compatibility and high performing Deep knowledge of Angular or AngularJS practices and commonly used modules based on extensive work experience. Creating custom, general use modules and components which extend the elements and modules of core Angular or AngularJS, when needed. Excellent understanding of OOP patterns and methodologies and experience with OO languages Experience with solving UI App memory and performance issues Attention to UI and UX details Thorough understanding of the responsibilities of the platform, database, API and other web services used in the system.

Educational Qualification with Specialization: Engineering Graduate or Post Graduate Preferred background in Life SciencesTop Primary Skills Required for this Role: 2+ years experience in a QA Lead or Test Lead role, or 4+ years experience as a Sr. QAE Proficient in testing methodologies Hands-on experience with test management and bug tracking tools Capable of test planning and execution Ability to prepare comprehensive status reports Secondary Skills Required for this Role: Strong verbal and written communication skills Attention to detail with superior problem-solving abilities Excellent organizational and time management skills Knowledge of SDLC Familiarity with 21 CFR Part 11 is an added advantage Tertiary Skills Required for this Role: Capacity to operate in a flexible, dynamic environment requiring creative and strategic thinking Ability to work with demanding users in a high-pressure environment Essential multi-tasking abilities Job Description: Understand project scope, goals, and deliverables in collaboration with senior management and stakeholders Communicate project expectations to team members and stakeholders effectively and timely Develop test plans, mitigate risks to system quality, and obtain stakeholder support Identify training requirements and forward them to the Project Manager Estimate and secure management support for the necessary time, resources, and budget for testing Assign tasks to testing team members and ensure sufficient workload distribution Maintain the content and structure of all testing documents/artifacts Implement, monitor, and enforce testing processes as per organizational standards Review test case documents and resolve project team conflicts Manage project expectations, dependencies, and critical paths Track project milestones, deliverables, and prepare reports on testing activities Monitor new or changing project requirements Escalate project requirement issues to the Project Manager/Management Organize status meetings and send reports to stakeholders