Are you a Validation Lead who can manage multiple projects, build strategy and support CSV initiatives?
SQA is working with a fast growing bio-pharmaceutical company. We are looking for a Senior Validation Lead to join and existing Clinical IT team and help lead several projects. The work is focused on developing validation strategies, planning and ensuring all deliverables are in place while following the IT QMS/SOP’s. Additionally you will be supporting inspection readiness, help to refine Validation SOP’s and interface with Vendors as they supply scripts and validation documentation. As the validation lead you will be responsible for conducting risk assessments and ensuring change management/control are incorporated as part of the validation strategies.
Critical Success Factors:
- 7+ years in a Validation role, strong leadership skills and the ability to work in a dynamic and fast paced environment
- 2+ Years as a Validation Lead, able to manage multiple projects at one time
- Experience developing Validation artifacts: strategies, plans, traceability matrices, summary reports
- Experience working on SaaS based platforms and with vendors to integrate validation approaches
- Experience in supporting inspection readiness
- Experience with instilling Change Management/Control best practices
- Experience with GcP
Job ID: 2006-5892
SQA is an equal opportunity employer and supports workforce diversity.