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Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Plan and conduct independent clinical (GCP) audits to assess compliance with regulations, guidelines, and operating procedures.
- Prepare and distribute reports of findings to supervisor, operations staff, management, and customers.
- Provide consultation in interpretation of regulations, guidelines, policies, and procedures.
- Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.
- Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions.
- Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
- Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
- Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans.
- Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closure for quality events arising from Audits; and from Quality Issues, Inspections or during similar QA activities as assigned.
- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
- Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle.
- Lead/collaborate/support in QA initiatives/projects for quality, process improvements.
- Assist in training of new Quality Assurance staff.
- May be required to manage Quality Issues.
- May present educational programs and provide guidance to operational staff on compliance procedures.
- May perform pre-inspection visits at sites, host audits/inspections; ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections, as assigned.
Requirements
What you’ll need- 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance Audits.
- Certified to conduct audits in Italy in accordance with the Italian Decree of the Ministry of Health dated 15 Nov 2011.
- Experienced in the conduct of clinical trial Investigator site audits.
- Knowledge of word-processing, spreadsheet, and database applications.
- Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
- Knowledge of quality assurance processes and procedures.
- Strong interpersonal skills.
- Excellent problem solving, risk analysis and negotiation skills.
- Strong training capabilities.
- Effective organization, communication, and team orientation skills.
- Ability to initiate assigned tasks and to work independently.
- Ability to manage multiple projects.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Benefits
Comp & perks- Health insurance
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Clinical Trial AuditsQuality Management System (eQMS)Risk AnalysisNegotiation SkillsReport PreparationProcess ImprovementRegulatory Guidelines InterpretationTraining CapabilitiesProject ManagementCompliance Assessment
Soft Skills
Interpersonal SkillsProblem SolvingEffective CommunicationTeam OrientationOrganizational Skills
Certifications
Audit Certification in Italy