Ensure IT validation packages are inspection ready and in compliance with applicable company policies and procedures.
Work autonomously with related IT contacts and the business process SMEs for this purpose.
Support as SQA the testing and implementation of regulated IT applications.
Ensure continuous improvement and gives input related to the validation strategy for IT changes.
Collaborate with the development team to build compliance capabilities in order to assure the quality of the deliverables and ensures business needs are met.
Detailed Job Description:
Must have previous experience validating systems that include Salesforce
Proficient in understanding of GxP regulations and validation principles
Strong analytical skills with the ability to organize work in a logical, thorough and succinct manner.
Highly self-motivated, self-directed
Understanding of risk management principles, regulatory requirements and, industry best practices.
Knows the difference between Waterfall and Agile software development methodologies
Previous experience with automated testing and implementation
Familiarity with a range of applications including JIRA, Confluence, HP-ALM, M-Files, Microsoft Teams, Data Lake, AWS, Tresata (Apache Hadoop), Databricks, Github, or other continuous integration tools
Flexibility to adapt to changing priorities
Effective with written and verbal in English communications at all levels, providing input and regulatory guidance to project teams
Role must maintain compliance expertise and be effective at applying requirements in the IT and business environment that supports business goals and maintaining a compliant state.
Authorized to work in the United States for any employer or be able to provide proper documentation if associated with a third-party agency
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