SQA Specialist

As an IT Validation Specialist, you will play a crucial role in ensuring that IT validation packages are inspection ready and in compliance with company policies and procedures. You will work autonomously with IT contacts and business process SMEs to support the Review and Approval and implementation of regulated IT applications. Your responsibilities will also include collaborating with the development team to build compliance capabilities, writing and executing SDLC deliverables, and reviewing CAPAs, Change Control, and Defects as they relate to software validation. Key Responsibilities: - Ensure IT validation packages are inspection ready and in compliance with company policies and procedures - Work autonomously with IT contacts and business process SMEs - Support as SQA in the Review and Approval and implementation of regulated IT applications - Ensure continuous improvement and provide input related to the validation strategy for IT changes - Collaborate with the development team to build compliance capabilities - Write and execute SDLC deliverables - Review and approve SDLC deliverables - Review CAPAs, Change Control, and Defects as it applies to software validation Qualifications Required: - Previous experience validating systems - Proficient in understanding of GxP regulations and validation principles - Experience in SDLC/Software Validation with several years of SQA experience - Strong analytical skills with the ability to organize work logically - Understanding of risk management principles, regulatory requirements, and industry best practices - Knowledge of Waterfall and Agile software development methodologies - Previous experience with automated testing and implementation - Familiarity with applications/tools including JIRA, Confluence, Client-ALM, Tosca, Veera, Qtest, M-Files, or other continuous integration tools - Effective written and verbal communication skills in English - Role must maintain compliance expertise and apply requirements in the IT and business environment to support business goals and maintain a compliant state. As an IT Validation Specialist, you will play a crucial role in ensuring that IT validation packages are inspection ready and in compliance with company policies and procedures. You will work autonomously with IT contacts and business process SMEs to support the Review and Approval and implementation of regulated IT applications. Your responsibilities will also include collaborating with the development team to build compliance capabilities, writing and executing SDLC deliverables, and reviewing CAPAs, Change Control, and Defects as they relate to software validation. Key Responsibilities: - Ensure IT validation packages are inspection ready and in compliance with company policies and procedures - Work autonomously with IT contacts and business process SMEs - Support as SQA in the Review and Approval and implementation of regulated IT applications - Ensure continuous improvement and provide input related to the validation strategy for IT changes - Collaborate with the development team to build compliance capabilities - Write and execute SDLC deliverables - Review and approve SDLC deliverables - Review CAPAs, Change Control, and Defects as it applies to software validation Qualifications Required: - Previous experience validating systems - Proficient in understanding of GxP regulations and validation principles - Experience in SDLC/Software Validation with several years of SQA experience - Strong analytical skills with the ability to organize work logically - Understanding of risk management principles, regulatory requirements, and industry best practices - Knowledge of Waterfall and Agile software development methodologies - Previous experience with automated testing and implementation - Familiarity with applications/tools including JIRA, Confluence, Client-ALM, Tosca, Veera, Qtest, M-Files, or other continuous integration tools - Effective written and verbal communication skills in English - Role must maintain compliance expertise and apply requirements in the IT and business environment to support business goals and maintain a compliant state.