Sr. QA Auditor, GCP
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Job Location:
Livingston - UK
Monthly Salary:
Not Disclosed
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Overview
Plan and conduct independent 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.
Essential Functions
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
Manage Quality Issues
Present educational programs and provide guidance to operational staff on compliance procedures
Review approve investigations Root Cause Analysis (RCA) Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closures for quality events arising from Quality Issues Audits Inspections or during similar QA activities
Provide quality assurance consultancy activities and projects for clients within budget and established timelines
Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
Host audits/inspections
Ensure proper conduct of customer-initiated audits and mock regulatory inspections and assist in regulatory facility inspections
May perform GLP Archivist duties where needed
Manage/oversee quality events updates in eQMS and/or 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
Qualifications
Ability to travel 15-20% across Europe
10 years experience in pharmaceutical technical or related area of which 5 years in Quality Assurance.
GCP audit experience is a must.
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..
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.
This role is not eligible for UK Visa sponsorship.
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
Required Experience:
Senior IC
Key Skills
- Auditing
- Time Management
- ICD-10
- Accounting
- Component evaluation
- Workers' Compensation Law
- SOX
- Microsoft Excel
- CPT Coding
- Internal Audits
- Medicare
- Bookkeeping
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
