6 Regulated Environment Jobs

As a QA Technical Senior Associate at our company, your role will involve supporting Quality Assurance initiatives, with a primary focus on Technical Writing, Document Management, and Business Performance. You will be responsible for executing key QA documentation processes, system coordination, and project-related administrative functions to ensure compliance with Quality Management System (QMS) expectations and operational efficiency. Additionally, you may need to lead a shift-based team to provide coverage in support of the Amgen network across multiple time zones. Key Responsibilities: - **Technical Writing and Document Management:** - Manage requests for site licenses and country-specif...

Job Title Software Technologist I - Test Job Description At least 5 to 7 years of experience in software testing and preferably in healthcare domain Experience in system testing activities is advantage. Experience with testing frameworks including mocking technologies. Experience with and understanding of Git. Experience working in Scrum agile environment. Exceptional knowledge of object-oriented design, including design patterns. Strong ability to analyze requirements and develop a risk-based approach to testing. Good to have. Experience with Build Management & Continuous Integration systems (TeamCity or equivalent) Experience developing multi-threaded applications Experience with Test Auto...

As a Senior Validation Engineer at ValGenesis, you will play a crucial role in ensuring compliance and quality of innovative software solutions tailored for the life sciences sector. Your responsibilities will include: - Working hands-on in an individual capacity to deliver results. - Collaborating with Product, Engineering, and Testing teams to understand Product functions. - Reviewing Product Requirements such as Epics, User stories, and Software Requirements. - Authoring test cases in OQ and PQ protocols in alignment with requirements and QMS guidelines. - Generating realistic test cases and test data based on customer scenarios. - Executing test cases, reporting test results, and creatin...

As a Data Use Management Analyst in the Legal Data Office, you will play a crucial role in guiding stakeholders through the data use lifecycle to ensure that every data request meets the highest standards of governance and compliance. You will collaborate with cross-functional teams, support decision-making processes, and help foster a culture of responsible data use. Your contributions will enable secure, ethical, and innovative applications of legal data, aligning with both business transformation objectives and regulatory requirements. **Job Responsibilities:** - Implement and maintain standard operating procedures for legal data use - Guide stakeholders through data sharing and approval ...

As a Senior Validation Engineer at ValGenesis, you will play a crucial role in ensuring compliance and quality of the innovative software solutions tailored for the life sciences sector. Your responsibilities will include: - Working hands-on in an individual capacity to deliver project milestones. - Collaborating with Product, Engineering, and Testing teams to understand product functions. - Reviewing various product requirements such as Epics, User stories, and User Requirements. - Authoring test cases in OQ and PQ protocols in alignment with requirements and QMS guidelines. - Generating realistic test cases and test data based on customer usage scenarios. - Executing test cases, reporting ...

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...