Senior Specialist Quality Assurance Remote 6 months Qualifications: Advanced knowledge of end-to-end PV procedural requirements Ability to review/direct PV procedural documents to ensure compliance with international standards and regulations while also promoting a lean and efficient procedural framework. Mid-level understanding of quality management, change control, and quality management systems. Ability to learn and work in ETQ. Advanced ability to work within fixed timelines and manage a high volume of work/multiple projects at one time. Responsibilities: Advise Global PV teams on change control of procedural documents before work is started to draft revisions. Review change control documents to ensure Global PV business process owners are considering proper training as a part of the procedural changes. Review and approve procedural documents in ETQ to ensure they meet the needs to ensure quality and compliance and strategically move towards a more lean and efficient procedural document framework governing pharmacovigilance and safety surveillance . Comments/Special Instructions Anyone with experience using ETQ (a quality management system) would be preferred.
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