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Job Details

Sr. QA Auditor (Senior GCP Auditor)

Company: Chiltern
Location: Home or Office based in the U.S.
Reference: 6520
Closing Date: 22 Mar 18
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

The Senior QA Auditor is responsible for Quality Assurance aspects of clinical trials, ensuring trials conform to ICH-GCP, other applicable regulations and the relevant Standard Operating Procedures (SOPs). The QA Auditor is independent of the Clinical Research Team.

Requirements:

Job Background

 

In this role, the main overall responsibilities of the position are the following:

  • Plan, prepare and conduct trial specific, quality system, and vendor qualification audits and report findings to the auditees.
  • Create QA SOPs required for the proper functioning of the clinical trial process.
  • Act as Quality Project Lead (QPL) on assigned studies, ensuring quality related oversight of projects and to act as a QA point of contact for study team members.
  • Audit the quality of the clinical trial against the defined project-specific quality and performance standards as well as relevant SOPs, ICH/GCP, and local requirements; prepare audit reports within a timely manner; identify any failure to meet the standards and address the issue immediately with the Project Manager; and if required, with Chiltern Senior Management.
  • Hosts client audits and supports regulatory inspections activities (as applicable).
  • Provide regular feedback to the QA Audit Management team about the quality standards practiced in the company and give recommendations for their improvement.
  • Conduct project specific, internal system audits and vendor audits to assess the quality standards and provide recommendations; prepare audit reports within a timely manner.
  • Provide GCP consultancy and advice in response to questions raised by individuals from the organization.
  • Ensure that systems and processes agreed and implemented by management will ensure that Clinical Trials have been performed, and data is generated, in compliance with ICH-GCP and other applicable regulations.
  • Be aware of updates to regulations, guidelines and principles related to Good Clinical Practice (GCP) and advise on their use and compliance.

Desired Skills and Experience

  • University Degree in a biomedical or related life science, or nursing preferred
  • Minimum 5+ years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
  • Must have experience preforming clinical site audits (GCP)

Salary

depends upon experience

Position Type

Permanent
Full Time

Contact

Email Michelle Gerardi - Michelle.Gerardi@Chiltern.com
+1 774 272 5506

Apply for this job: Sr. QA Auditor (Senior GCP Auditor)

Contact Information:

Address:  Illinois, USA
1425 Tri-State Parkway, Suite 110 Gurnee, USA
IL 60031
USA
Website:  Visit Our Web Site

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