Seeking candidature of candidates with minimum 10 years of experience in Corporate Quality Assurance (CQA). CQA candidates from CROs preferred. Roles & Responsibilities

• Implement systems that allow DDReg to meet its commitment to quality and add value for the customers.
• Continuous review of working levels processes to ensure compliance wrt the working level SOPs set within the Company.
• Constant upgrade of the Standard Operating Procedures as per applicable guidelines.
• Single Point of Contact for audits by client and for inspections by Health Authorities.
• Participate in Audits/inspections to ensure quality, integrity, and compliance with respect to ISO and regulatory requirements.
• Identify training needs of the working level teams from a compliance perspective.
• Identify and assess potential risks to quality, business continuity plan and work with senior leadership to develop mitigation strategies.
• Participate in risk management activities across projects and processes.
• define quality standards for each function within the organization.
• stay updated with global corporate quality Assurance standards.
• Monitoring and reporting on the quality of systems compliances.

  Preferred Skills

• Quality check
• Reasoning and scientific skills
• Assessment skills
• Analytical and persuasion
• Good communication
• Collaborative working

Job Overview DDReg Pharma Pvt Ltd is seeking a front-end web developer to build new web pages and improve our company website. The right person for this role will be proficient in HTML, CSS, JavaScript, and PHP. You will be responsible for building and deploying new front-end features to our website, handling the integration of plugins whenever required and performing routine maintenance of our site. Key Responsibilities

• Build and optimize a secure web page for evolving business needs.
• Create and maintain websites using HTML, CSS, JavaScript, and other programming languages. This includes developing user interfaces and ensuring responsive design across devices
• Provide continued support for one or more web properties.
• Work closely with graphic designers, SEO team, and Digital Marketing team to gather requirements and translate them into functional websites. Regular meetings with stakeholders to review project scopes are common.
• Maintain communication with team members and supervisors concerning the direction of the website.
• Code and script applications.
• Conduct testing to ensure compatibility across different browsers and devices, troubleshoot issues, and implement fixes. This includes performing unit tests and user acceptance testing.
• Integrate data from various back-end services and databases. Familiarity with content management systems like WordPress or Drupal is often required.
• Perform routine site audits, as well as ongoing maintenance, on an as-needed basis.

Required Skills:

• Web development fundamentals, including HTML, CSS, and JavaScript
• Front-end JavaScript frameworks such as Vue, React, and Angular
• Back-end frameworks such as Ruby on Rails, Node.js, and ASP.NET
• Content management systems (CMSs) such as WordPress, Joomla, and Squarespace
• UI/UX design experience
• Working knowledge of graphic design
• REST API development
• Relational databases such as MySQL
• Agile and test-driven development best practices
• Understanding of search engine optimization (SEO) practices
• Excellent written and verbal communication skills
• Strong interpersonal skills
•  Ability to troubleshoot complex issues and implement effective solutions independently or as part of a team
• Ability to work independently and manage time efficiently
• Solution-oriented and high-level programming skills
• Ability to troubleshoot and optimize web pages for security and responsiveness
• Understanding of network diagnostics and analytical tools

  Experience and Educational Requirements:

• Experience: 2+ Years
• A bachelor's degree in computer science, software development or a related field

Job Description

Job title	AGM/Senior Manager
Reports to	Director

Job purpose To Manage Regulatory Affairs for Emerging (RoW) Markets/Regulated Markets (Eu/US/Canada/Japan/UK/Australia)  in compliance to applicable regulations and guidelines. The responsibility include review of technical documents/dossiers, preparation and submission of Submission dossiers in CTD format, ePublish them (wherever applicable), response to queries, post approval life cycle management etc. This position will also provide support of the regulatory function through document management, electronic submission compilation and management, and other group management activities as required. Position will be required to work with Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Research and Development groups of the client organization of DDReg. Duties and responsibilities

• Providing high-quality CMC review of technical documentation for regulatory filings to various markets – key market being Saudi & GCC, for DDReg clients
• Actively contribute to the development and implementation of regulatory strategies, processes and timelines for grant of MAs.
• Prepares and compiles new CTD dossiers, renewals and variations ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
• Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
• Demonstrate subject matter and area expertise.
• Collaborate with internal and external clients,
• Supporting and enabling effective and efficient communication that results in operational excellence.
• Manage multiple projects with the help of team, track the status of each project, provide update to management in a time bound manner, monitor efficiency of team members.
• Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices.
• Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.
• Monitor competitive regulatory practices, and actively review internal and external factors to mitigate potential problems.
• Ensure that draft labeling complies with all applicable regulations and guidelines

Education & Experience

• Bachelor's or Master’s degree in Pharma
• Previous experience of minimum 7 years that provides the knowledge, skills, and abilities to perform the job.

Knowledge, Skills and Abilities

• Excellent technical data interpretation skills
• Strong project management skills
• Excellent interpersonal skills including problem solving
• Strong negotiation skills
• Excellent oral and written communication skills with strong presentation skills
• Significant knowledge of global, regional, national and other document development guidelines
• In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
• Great judgment and decision-making skills
• Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
• Ability and desire to work in a team-oriented environment.
• Excellent written and verbal communication skills
• Highly proficient with Microsoft Word, PowerPoint and Excel.
• Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
• Possesses a collaborative, results-driven style.
• Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines

Other requirements As may be required from time to time – the incumbent may be required to working slots catering to different time zones Location Gurgaon, Haryana (INDIA)  

Job Description

Job title	Software Development Team Lead
Reports to	Director

Responsibilities:

• Works closely with the Product Leads to have a solid understanding of business and product.
• Is accountable for the applications the Dev teams develop and assists with questions and PROD support when needed;
• Capable of understanding and contributing to the technical solution from design through to code level
• Able to analyze and evaluate technical risks within the scope of a project and make judicious recommendations;
• Define delivery phases of the project including activities, sub-activities, and milestones ensuring these are documented and used as the basis for the project event log, issues and risk log and any subsequent reporting
• Ensure awareness, involvement and support from the key stakeholders and participants by building strong project teams and maintaining robust communication on the project status throughout its life
• Works with Training department to communicate changes to internal and external users;
• Responsible for delivering projects on budget, on time, to requirements, and with high quality;
• Managing the delivery of multiple complex simultaneous system development projects from design through to release
• Should be competent presenting technical information to a range of audiences including non-technical audiences;
• Leads a team working on significant and critical projects. Provides both technical and team leadership and mentoring;
• Responsible for performance evaluations of team members and assisting in the compensation process;

Requirements:

• Comfortable with documentation and creating infrastructure diagrams;
• Comfortable communicating directly with clients;
• Git, Source Tree;
• Worked in an Agile environment;
• Healthcare IT experience;
• Understanding of SOA development;
• Ability to write quality unit tests;
• Possess strong understanding of traditional RDBMS and distributed computing;
• Development on Linux;
• Experience/Knowledge with Spark and Scala;
• Experience in Spring, Hibernate, REST, ORM, JPA;
• Experience with AGILE software development methodology;
• Understanding of repeatable automated processes for building the application, testing it, documenting it, and deploying it at scale;
• Experience/Knowledge in web and backend design and development;
• Experience/Knowledge in UI frameworks and libraries like jQuery, ReactJS, Play, or AngularJS.

Education and Experience:

• Bachelors degree in Computer or Information Science-related field required; Masters degree preferred.
• At least three years of related experience required.

Location: Gurgaon, India (On-Site)