IQVIA
SrQualitySpecialist
“Sr Quality Specialist at IQVIA. Skills: Quality management, Risk assessment, GCP compliance. Implement Global Quality Management Plan. Adapt Global Quality Management Plan”
What You'll Achieve.
Improve compliance with ICH; Improve compliance with GCP; Improve compliance with regulatory requirements; Improve compliance with SOPs; Improve compliance with KPIs; Improve quality; Improve operational effectiveness
Industry & Context.
Root cause analysis
2-3 days per week in office, Some travel required, Not eligible for UK Visa sponsorship
What They're Looking For.
Must Have
Bachelor’s degree, 4 years clinical research experience, Monitoring experience
Nice to Have
Experience in quality management, Experience in quality oversight, Experience participating in audits, Experience participating in regulatory inspections, Experience delivering training, Experience contributing to training
What You'll Do.
Implement Global Quality Management Plan
Adapt Global Quality Management Plan
Plan quality management activities
Conduct quality management activities
Perform risk identification
Perform risk assessment
Support risk mitigation
Support CAPA planning
Provide guidance to improve quality
Provide guidance to improve operational effectiveness
Collaborate with business lines
Collaborate with key stakeholders
Provide expert advice on GCP compliance
Support management of non-compliance
Support management of quality issues
Ensure timely closure of CAPAs
Identify serious quality issues
Escalate serious quality issues
Inform business lines of quality issues
Inform QA teams of quality issues
Partner with QA teams
Partner with business teams
Support audit readiness
Support regulatory inspection readiness
Participate in audits
Participate in regulatory inspections
Conduct quality control visits
Prepare periodic reports
Deliver training sessions
Deliver knowledge-sharing sessions
Perform additional tasks
How You'll Work.
Team & Collaboration
Business lines; Key stakeholders; QA teams; Business teams
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