Senior QA Auditor/QA Manager

Senior QA Auditor/QA Manager Remote

IQVIA
Full Time Remote 10.56 - 12.04 GBP Today
Job description

Location: UK

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 simillar 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
  • Bachelor's Degree Pref
  • 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance. GXP experience. Equivalent combination of education, training and experience.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

Senior QA Auditor/QA Manager
IQVIA

www.iqvia.com
Durham, United States
Ari Bousbib
$10+ billion (USD)
10000+ Employees
Company - Public
Biotech & Pharmaceuticals
2017
Related Jobs

All Related Listed jobs

Food production operative
Intertek Derby, England 24848 - 44704 GBP ANNUAL Today

Ability to work accurately and quickly to controlled methods. You will have the opportunity to assist in ensuring the microbiological safety of the food that

Trainee Investment Consultant - 2023 Intake
Barnett Waddingham Amersham, England 48367 - 74989 GBP ANNUAL Today

Providing investment advice and services to a range of organisations, including pension schemes, local authorities, endowment funds, charities and high net

Assistant Hospitality Service Manager – F&B
Bournemouth Carlton Hotel, Signature Collection By Best Western Bournemouth, England Today

YOU will have at least 12 months management experience of working within a busy food and beverage environment.

Finance Systems Administrator - OneStream
Landsec London, England 45000 GBP ANNUAL Today

System administration: 2 years (preferred). Be the lead system administrator for OneStream; setting up user access, maintaining meta data, hierarchies etc.

legal assistant
Kids & Company Mississauga 44720 - CAD HOURLY Today

  • Education: College, CEGEP or other non-university certificate or diploma from a program of 1 year to 2 years
  • Experience: 1 year...