4 Kneat Jobs

The QA Technical Senior Associate plays a crucial role in supporting Quality Assurance initiatives within the Quality Operations Network, focusing on Technical Writing, Document Management, and Business Performance. In this position, you will be responsible for executing key QA documentation processes, coordinating systems, and performing project-related administrative functions to ensure compliance with Quality Management System (QMS) requirements and enhance operational efficiency. Your role will involve working during regular business hours to assist Amgen in fulfilling its mission of serving patients, potentially leading a shift-based team that provides coverage across various time zones. You may be required to work outside standard hours to meet business needs and determine the same for your team. This position is based in our office in Hyderabad, India (Amgen India-AIN), and will involve leading remote support from AIN to Amgen sites globally. Your responsibilities will include: - Managing requests for site licenses and country-specific reports - Drafting and managing workflows for QA-owned procedures, including Standard Operating Procedures (SOPs) and Appendices - Conducting periodic document reviews and providing document system support using tools like DocuSign and Kneat - Creating and maintaining Smartsheet trackers and dashboards to support quality and business operations - Providing project coordination and administrative support for various activities, such as invoicing, expense reporting, audit logistics, and travel arrangements Preferred qualifications for this role include: - Experience in a GMP or regulated environment with exposure to quality documentation systems and tools - Strong attention to detail and demonstrated skills in document drafting and editing - Proficiency in document and project management systems like DocuSign, Kneat, and Smartsheet - Effective organizational and time management abilities to handle multiple priorities - Strong communication and interpersonal skills for cross-functional coordination - Ability to work independently within defined parameters and follow established procedures Key competencies for this position encompass: - Technical Writing and Document Control - System and Workflow Coordination - Business Operations and Project Support - Cross-Functional Communication and Collaboration - Organizational Agility - Detail-Oriented Execution Basic qualifications required for this role include a Masters degree with 5-9 years of experience in Pharma and Biotech commercial or clinical manufacturing Quality.,

CQV Engineer Job Description To support the CQV service, we are now looking to recruit an Electronic Validation Administrator. The successful candidate will play a key role in supporting our Electronic Validation (Eval) capability while collaborating with our existing CQV delivery teams and customers to enhance and develop our overall CQV service delivery. The role requires the ability to manage the setup & administration of current EVal platform (Kneat) as well as future EVal software. The role will also require the administration of client EVal instances when required for projects. The successful candidate will work closely with client digital teams to agree the implementation of EVal on their projects, as well as communicating and integrating the CQV requirements between engineering and construction functions. This part time (hybrid) role will report to CQV Electronic Validation Lead based in the India offices. Responsibilities .Understand EVal strategy aligned with the company's overall objectives and vision. Ensure the digital platforms are in place and setup correctly to deliver the EVal service for our clients. Ability to interface with clients and build relationships to grow the EVal delivery business. Administration support on both internal and client Kneat platforms Ability to draft, review and approve electronic documentation Upkeep of PM Group CQV EVal template libraries Progress updates to manager at weekly work plans Qualifications .Ideally, a Primary Degree in an Engineering related discipline with 5+ years experience in CQV/pharma. Demonstrated capability & expertise in the use of EVal platforms- Preferably Kneat and/or Valgenesis. Ability to work on ones own initiative. Excellent communication skills. Past training with Kneat Academy advantage Why PM Group ? As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future

What you will do In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers to create high-quality, scalable software solutions and automating operations, monitoring system health, and responding to incidents to minimize downtime. Roles & Responsibilities: Lead the design, configure and deployment of the validation systems (such as Veeva Validation Management, ALM, and KNEAT) ensuring scalability, maintainability, and performance optimization. Implement best practices, conduct code review and provide technical guidance, mentorship to junior developers. Take ownership of complex software projects from conception to deployment. Manage software delivery scope, risk, and timeline Collaborate closely with business collaborators to discuss requirements, ensuring alignment between technical capabilities and business objectives, while effectively communicating any technical limitations or constraints. Contribute to both front-end and back-end development using cloud technology. Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations. Ensure all documents are compliant with 21 CFR Part 11, Annex 11, and other relevant regulations. Identify and resolve technical challenges effectively. Stay updated with the latest trends and advancements. Work closely with product team, business team, and other collaborators. Work closely with multi-functional teams, including product management, design, and QA, to deliver high-quality software on time What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Masters degree with 4 - 6 years of experience in Computer Science, IT or related field experience OR Bachelors degree with 6 - 8 years of experience in Computer Science, IT or related field experience OR Diploma with 10 - 12 years of experience in Computer Science, IT or related field experience Strong technical background, including understanding software development processes, databases, and cloud-based systems. Experience configuring the SaaS systems such as Veeva or ALM. Proficiency in one or more programming languages such as Java, Python, or JavaScript and familiarity with API-driven content delivery. Experience working with databases (SQL/NoSQL), and GenAI. Preferred Qualifications: Understanding of Veeva Quality Vault/ALM/KNEAT. Curiosity of modern technology domain and learning agility Experience with the following technologies: Veeva Vault, MuleSoft, AWS (Amazon Web Services) Services (DynamoDB, EC2, S3, etc.), Application Programming Interface (API) integration and Structured Query Language (SQL) will be a big plus. Excellent communication skills, with the ability to convey complex technical concepts. Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills.

What you will do In this vital role you will we are seeking a highly skilled Associate IS Bus Sys Analyst to join our team. You will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers to create high-quality, scalable software solutions and automating operations, monitoring system health, and responding to incidents to minimize downtime. Roles & Responsibilities: Maintain existing code and configuration: Support and maintain SaaS applications Development & Deployment: Develop, test, and deploy code based on designs created with the guidance of senior team members. Implement solutions following standard methodologies for code structure and efficiency. Documentation: Generate clear and concise code documentation for new and existing features to ensure smooth handovers and easy future reference. Collaborative Design: Work closely with team members and collaborators to understand project requirements and translate them into functional technical designs. Code Reviews & Quality Assurance: Participate in peer code reviews, providing feedback on consistency to standard methodologies, and ensuring high code quality and maintainability. Testing & Debugging: Assist in writing unit and integration tests to validate new features and functionalities. Support fix and debugging efforts for existing systems to resolve bugs and performance issues. Perform application support and administration tasks such as periodic review, manage incident response and resolution, and security reviews. Continuous Learning: Stay up-to-date with the newest technologies and standard methodologies, with a focus on expanding knowledge in cloud services, automation, and secure software development. What we expect of you Must-Have Skills: Solid technical background, including understanding software development processes, databases, and cloud-based systems. Experience configuring SaaS applications (such as Veeva). Experience working with databases (SQL/NoSQL). Strong foundational knowledge of testing methodologies. Good-to-Have Skills: Understanding of Veeva Quality Vault/ALM/KNEAT. Curiosity of modern technology domain and learning agility Experience with the following technologies: Veeva Vault, MuleSoft, AWS (Amazon Web Services) Services (DynamoDB, EC2, S3, etc.), Application Programming Interface (API) integration and Structured Query Language (SQL) will be a big plus. Superb communication skills, with the ability to convey complex technical concepts. Qualification: Bachelors Degree and 0 to 3 years of experience in software development processes, databases, and cloud-based systems Diploma and 4 to 7 years of experience in software development processes, databases, and cloud-based systems