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QA Auditor II

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About the role

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"At ICON, it's our People that set us Apart"
 
ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 83 locations in 38 countries and has approximately 12,600 employees. Further information is available atwww.iconplc.com
 
 
Senior QA Auditor
Role Responsibility
 
 
  • Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance
  • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
  • Travel (approximately 35%) domestic and/or international
  • Have a thorough knowledge of all relevant ICON SOPs, ISO requirements and appropriate regulations and guidelines
  • Effectively plan and conduct regular and random QA audits (internal and external) in order to assure that clinical studies managed by ICON are of the highest standard and are in compliance with the requirements of ICON or Sponsor SOPs, study protocols, relevant regulations and guidelines and with ISO 9000 requirements
  • Perform quality system audits if required
  • Perform contract audits for Sponsor companies as required
  • Ensure that audit results are formally recorded and reported and that corrective/preventive actions are documented
  • When appointed lead auditor, perform the duties assigned in an efficient and effective manner. This includes liaison with the project manager on all QA issues, including audit planning and review of audit results
  • Assist with the development of the project audit procedures
  • Train QA auditors, and provide a benchmark of auditing competencies to less experienced colleagues
  • Assist in training ICON staff regarding GCP, ISO 9000, role of QA, regulatory audits etc.
  • Conduct induction/orientation of new staff in ICON quality policies and procedures
  • Assist with business development activities, including the preparation of cost proposals/contracts, and attend marketing presentation, when appropriate
  • Assist with the co-ordination of Sponsor and Regulatory audits within the (specify office/region) and assist at such audits as necessary
  • Carry out a senior role in the regional QA department (Project Audits), including scheduling of audits, supervision of relevant auditors and review of audit results
  • Assist with the management of the department when requested and authorized by the QA manager or higher
  • Keep the person whom the Senior QA Auditor reports to informed of any QA issues within the department that require attention.
 
Benefits of Working in ICON
 
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
#LI- SZ1 
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