Commitment: Full Time
- Ensures IT validation packages are inspection ready and in compliance with applicable Company policies and procedures.
- Works autonomously with related IT contacts and the business process SMEs for this purpose.
- Supports as SQA the testing and implementation of regulated IT applications.
- Ensures continuous improvement and gives input related to the validation strategy for IT changes.
- Collaborates with the development team to build compliance capabilities in order to assure the quality of the deliverables and ensures business needs are met.
- Proficient in understanding of GXP regulations and validation principles
- Strong analytical skills and the ability to organize work in a logical, thorough and succinct manner.
- Highly self-motivated, self-directed.
- Familiarity with risk management principles, regulatory requirements and, industry best practices.
- Familiarity with Waterfall and Agile software development practices
- Familiarity with automated testing and implementation
- Familiarity with JIRA, Confluence, HP-ALM 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
- The 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.
- AQC (HP ALM)
- M-Files document management
- JIRA and Confluence
- Microsoft TEAMS
- Agile process
- Data Lake implementation in AWS
- Tresata (Apache Hadoop)