IT Validation Specialist (Clinical, R+D) (closed)
Reporting to the Sr. Director of Quality Systems, this position works collaboratively and effectively with IT and Business Owner stakeholders on IT validation project deliverables. This person prioritizes appropriately and incorporates a science-based risk management approach to actions and deliverables – providing QA review and approval of validation deliverables. This person would also bring validation subject matter expertise to the teams they would support.
- Provide Quality validation review support as Quality – IT liaison for computer system assessments, validation and change control, providing effective Quality support for all applicable support points of Software Development Lifecycle (SDLC).
- Provide lead validation support for IT change management documentation review. Ensure Quality & Compliance requirements are considered in any initiative or major change request.
- Perform timely and effective QA review of validation documentation such as SOP's, Master Validation Plan, Traceability Matrix, Testing deliverables, and Data Migration Plans.
- Provide timely updates on projects and deliverables to Quality Management and any other functions that support IT validation project deliverables (e.g. Document Management)
- Support and foster an environment conducive to innovation, high productivity, and high quality.
- Bachelors Degree with at least 5-10 years experience in the GXP pharmaceutical industry, including proven experience in supporting QA validation programs, advanced degree in technical field preferred.
- Direct experience in and responsibility for performing QA review of IT system validation documentation
- Proven and effective communication and interpersonal skills to influence, resolve conflict and leverage alignment with key stakeholders at all levels organizationally internally and externally.
- Ability to identify and clarify complex problems and constructively provide potential solutions to team.