*Validation Test Manager with Software Quality Assurance (SQA)* methodologies
*Remote* *Long Term* *Job Description:* · 10 + years of experience in managing Software QA teams within federally regulated industries or CSV teams in the Pharmaceutical / Biotech industry with comprehensive expertise and working knowledge of GxP, 21 CFR Parts 11, and Annex 11 compliance requirements, in implementing and maintaining GXP computer systems in a validated state · Strong working knowledge in validation methodology (including GAMP) and software development life cycle (SDLC) principles, Agile development, and deployment approach. · Hands-on experience with *Software Quality Assurance (SQA) methodologies*, techniques, approaches, and test automation tools. · Demonstrated ability to think strategically about business, product, and technical challenges from an enterprise perspective experience Fluid collaboration skills across business, IT, and external vendors/suppliers Preferred Experience Experience with the Cloud preferably AWS and key approaches to security and change management/deployment (infrastructure as code) Fluency in supporting the digitization of Computer Software Assurance processes by bringing the QA know-how to peers in Digital. · Builder mentality that seeks to produce innovation, agility, and velocity to support business-as-usual operations and new project implementation. · Looking for a highly motivated, experienced individual to build our automated testing tools with solid functional skills and a passion for testing software. · This individual sees opportunities in challenges, a path forward where it has never been tried before and is seeking to build data integrity throughout the modern operation. Roles and Responsibilities · Demonstrate extensive abilities and a proven record of success as a team leader in designing & developing Test Automation Frameworks Responsible to innovate and implement test automation to reduce manual test coverage Partner closely with the Digital System Owners along with software development teams to deliver automation and automated frameworks to ensure products and services work in a fully integrated manner as expected Work with the Biomanufacturing Applications team, Digital Security, Digital Operations, Digital Quality/Quality Systems, Project Management teams, and third-party vendor teams to ensure coverage and consistency in testing Work as part of a team of problem solvers, helping to solve complex business issues from testing strategy to execution Develop and apply a risk-based testing methodology to validation/qualification efforts in compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5 Develop and execute Digital Systems Development Lifecycle (SDLC) approach in support of GxP systems across the Resilience network. These include custom software systems, custom technology platforms, COTS configuration systems, cloud infrastructure, and SaaS used at Resilience in support of GXP operations. Collaborate with Digital Quality to maintain a state of control and compliance with established Quality Systems across the Resilience network. · Prioritize the enablement of test automation and efficiency within the SDLC (e.g. requirements, business process maps, test case management, automated regression testing, and traceability) Ensure the IT resilience of our manufacturing operations maintains consistency by driving accountability in the usage of templates for testing artifacts including test plans, test cases, test execution, and summary reports to ensure repeatability and compliance with our GxP and Quality process and standards. · Design and create automated solutions that cover end to end testing encompassing upgrade, regression, patching, performance, and security Familiarity with tools like Selenium, Robot Framework, Jenkins, XRAY, Micro Focus ALM, Atlassian products, and scripting automation tools Experience creating data-driven framework with solid analytical and problem-solving skills Experience working in agile development, CI/CD, data analysis, and data querying skills Qualification: · B.S. degree in Computer Science, Engineering, or related field with 12+ years of relevant progressive experience, within the pharmaceutical/biotech industry Thanks & Regards, Srikanth Reddy. G [image: svk-logo-tech individual] SVK Technology Solutions, Inc Email: srikanthre...@svktechinc.com | www.svktechinc.com 51 Cragwood Rd, Suite 301, South Plainfield, NJ 07080 PH: 609-904-0029 | Fax: 609-754-3700 An E-Verified company |An-Equal Employment Opportunity Employer Opportunity Employer -- You received this message because you are subscribed to the Google Groups "Android Discuss" group. To unsubscribe from this group and stop receiving emails from it, send an email to android-discuss+unsubscr...@googlegroups.com. To view this discussion on the web visit https://groups.google.com/d/msgid/android-discuss/CAJ%2BqChgiWSNzq1M3Ty3z3Etvwf9yCnQ-QcWwNJE662gskPs5bw%40mail.gmail.com.
