Support quality issues management, Customer Audit / Regulatory Inspections report response management, Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plan review, approval, and closure. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance with regulations, guidelines, and corporate policies. Lead / support QA initiatives / projects for quality process improvements.Essential Functions
Support audit response activities across countries involved with IQVIA contracts, assessing compliance with applicable regulations, guidelines, customer requirements, Standard Operating Procedures (SOPs), and project-specific instructions.Evaluate audit findings and prepare / distribute responses to operations staff and management.Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, policies, and procedures.Assist staff in interpretation of audit observations.Manage Quality Issues.Review and approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA), and Effectiveness Check (EC) plans. Track until closure for quality events arising from Quality Issues, Audits, Inspections, or similar QA activities.Present educational programs and guide operational staff on compliance procedures.Provide quality assurance consultancy activities and projects for clients within budget and timelines.Evaluate policies and procedures for compliance and recommend continuous process improvements.Assist in training new Quality Assurance staff.Support QA initiatives / projects for quality process improvements.Manage / oversee quality events in eQMS.Maintain the electronic quality management system (eQMS) and support the audit lifecycle.Qualifications
Bachelor's Degree preferred.At least 3 years of experience in pharmaceutical, technical, or related areas including GXP and / or Quality Assurance. Equivalent education, training, and experience considered.Knowledge of word processing, spreadsheets, and database applications.Considerable knowledge of GXP regulations and QA auditing techniques.Strong interpersonal, problem-solving, organizational, communication, and team skills.Ability to initiate tasks and work independently.Ability to manage multiple projects.Ability to establish and maintain effective relationships with coworkers, managers, and clients.Additional info :
LIremoteAbout IQVIA
IQVIA is a leading global provider of analytics, technology solutions, and clinical research services to the life sciences industry. We aim to push the boundaries of human and data science to make a significant impact, helping our customers create a healthier world. Learn more at our website.Key Skills
CSS, Cloud Computing, Health Education, Actuary, Building ElectricianEmployment Details
Type :
Full-TimeExperience :
YearsVacancy :
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