Life Sciences/ Biotech/ Biopharma Validation Specialist Responsibilities: Ensures validation is executed as per the validation plan and/or system change request, and accuracy and quality of data for Q&R fields is maintained in the application inventory management system. Quality Assurance supports, and at times guides, the Business Process Owner, Business Process Expert, and IT team members who are executing the validation activities. Promote high, positive engagement from stakeholders with the process and team. Actively share knowledge and help solve problems with systemic issues driving positive, compliant impact, coaching/mentoring teams as well as assisting in problem-solving for systemic issues. This role will have documented approval actions in multiple deliverables in the QMS application. Perform record reviews to give feedback to authors/application owners. Gather and report data to monitor the validation execution quality and metrics/KPIs. Qualifications A minimum of 5 years, with 7+ years of experience working in a disciplined regulated industry, including validation of computer systems and systems security and control, and in the application of automated technology, particularly 21 CFR, ISO 13485, and GAMP 5. Solid Analytical skills with demonstrated ability to troubleshoot complex process/system issues. Understanding of applicable international and national laws, regulations and standards: FDA (CSV & CSA), ISO and EU regulations for medical devices and healthcare; especially FDA 21CFR Part 820/Part 11, ISO 13485/EU MDR and EU Annex 11. Understanding of current inspectional practices of FDA, notified bodies and other regulatory agencies including previous interface with such bodies during regulatory assessments or inspections.• Knowledge and experience in key QMS disciplines (e.g. production and process quality control, design quality control, product risk management, post market surveillance quality control as well as general QMS management) is preferred. High attention to detail. Strong organizational, writing/technical writing, (including clear logic and quality & regulatory compliance documentation approaches, good documentation practices), verbal, and interpersonal skills.
About the job We at Velocity-RCS are seeking a QA Tester to join our team. The ideal candidate should have 1-2 years of experience in software testing and a passion for delivering high-quality software products. Job Title: Software QA Engineer Roles and Responsibilities • Working experience of a minimum of 1-2 years in Manual Testing. • QA experience with manual testing of web sites, web services and backend applications in windows. • Working knowledge on tools like Jenkins, JIRA and GitHub. • Record problems and issues in accordance with the project's problem and issue management plans. • Creating, enhancing, debugging, and running the test cases. • Work with the application team to resolve any issues that arise out of the testing process. • Good understanding and experience in Agile test automation frameworks and approaches. Skills Required • Strong in Testing methodology, test framework design experience. • Strong analytical and problem-solving skills. • Understanding of QA methodologies, life cycle and processes • Positive and energetic work attitude. • Well-organized and disciplined, but also adaptable approach to work. • Able to multi-task and manage numerous deliverables effectively. Qualifications • Bachelor's degree in Computer Science, Engineering, or a related field • Strong knowledge of software testing methodologies and tools • Experience with manual and automated testing techniques • Excellent problem-solving and analytical skills • Strong communication and collaboration skills • Ability to work effectively in a fast-paced environment and meet deadlines If you have a passion for ensuring the quality of software products and have the skills and experience required for this role, we encourage you to apply for the position of Software QA Engineer. Role & responsibilities Preferred candidate profile