QA Auditor - Clinical Research

Hiringlink Solutions
  • Bangalore
  • Confidential
  • 5-15 years
  • 10 Sep 2015

  • Quality Control - Product/ Process

  • Pharmaceuticals/ Life Sciences/ Clinical Research, Hospitals/ Health Care
Job Description

Job Responsibility:

* Plan, schedule, conduct, report and close audit activities in any of the countries involved with Company contracts. Audits are conducted to assess compliance with applicable regulations/guidelines, customer requirements, Company SOPs and project specific guidelines/instructions

* Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.

* Host Customer Audits and Regulatory inspections aligned to GCP

* 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

* Prepare and review and approve corrective action plans

* Present educational programs and provide guidance to operational staff on compliance procedures

* Conduct 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 customer audits

* Assist in hosting mock regulatory inspections and regulatory facility inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as needed

* Ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections

* Assist in training of new Quality Assurance staff

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