SQA Group is a technology and advisory services firm in growth mode, partnering with Fortune 500 companies, large enterprises and mid-market organizations to help our clients drive transformation. We introduce a blend of emerging technology solutions, data science services, and consulting services to fuel our clients’ modernization initiatives.
We are looking for a IT Compliance Specialist-GxP Consultant to help our life sciences client that is looking create its own evidence packet that would streamline new client onboarding processes from a compliance and audit perspective. Your day-to-day will involve collaborating with IT Management, Global Quality, and internal and external auditors on initiatives associated with IT compliance with respect to US FDA GxP and similar international regulations, among other things.
What You Will Do:
- Handle internal and vendor audit documentation
- Leverage your strong GxP knowledge
- Capture and compile information from internal groups including IT, Facilities, InfoSec, and Quality
- Assist IT system owners in executing computer system validation, qualification, and change control activities (planning, documentation, testing, etc.) for regulated Global IT systems under
- GLP/GMP standards
- Assist with the authoring and document management of Global IT Standard Operating Procedures (SOPs) and Deviations
What You Bring:
- Excellent consulting, communication, and presentation skills
- Background in tech writing
- SOP experience, particularly working and training on SOPs
- Audit and validation experience
- Ability to work and communicate seamlessly with multiple stakeholders and manage varying expectations
Thank you for your interest in pursuing a career at SQA Group! SQA Group is an equal opportunity employer and supports workforce diversity. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities above are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.