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Opportunity for Senior Quality Assurance Auditor in INC Research

 

Clinical courses

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Post: Sr Quality Assurance Auditor (India)

Job Description:
We are looking to hire a Senior Auditor to join our Quality and Compliance Consulting team.

Responsibilities
1. Schedules, conducts and documents assigned audits of the projects in accordance with approved procedures, schedules and formats. Specific audit areas will include, but are not limited to:
a. Investigator Sites
b. Trial Master and Project Management Files
c. Data Management Activities and Files
d. Safety Reporting
e. Final Study Reports
f. Vendors
2. Leads for-cause audits to address suspected critical audit findings, fraud, or misconduct related to investigator sites, vendors, etc. These complex and highly sensitive audits may involve issues related regulatory violations, controlled substances, and other highly sensitive matters.
3. Conducts audit debriefs with project teams and/or sponsor as required.
4. Writes and issues audit reports in accordance with standard Company formats and timelines, ensuring clear communication of audit findings to the relevant project team members.
5. Follow up as appropriate to obtain audit response. Reviews responses to audit findings for appropriateness and completeness.
6. Maintains accurate and timely documentation of QA auditing activities.
7. Serves as a trainer and mentor to newly hired QA Auditors.
8. Serves as Global Lead Auditor on projects as assigned.
9. Maintains subject matter expertise through training (internal and external), review and/or preparation and presentation of papers, review of guidelines, and regulations, etc.
10. Participates in Trusted Process meetings such as Kick-off, Quick Start Camp, and Quality Finish Camp


Candidate Profile
BA/BS degree in the science/health care field or equivalent combined education and experience.
Extensive experience in clinical quality assurance auditing and conduct of vendor audits (e.g. of central laboratories, clinical suppliers, IRBs, etc).
Strong knowledge of all applicable Good Clinical Practice regulations and guidelines.
Ability to handle multiple tasks to meet deadlines in a dynamic environment.
Strong organizational, presentation, documentation and interpersonal skills with diverse cultures.
Ability to negotiate and provide constructive feedback.

Additional Information:
Experience: 1-2 years
Location: India

"Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 17th February, 2015


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