Quality Assurance Auditor II

The QA Auditor supports the functional head of QA in the provision of quality assurance activities within Novotech, primarily in audit activities.

Responsibilities:

• Assist with the planning and hosting of client audits and/or regulatory inspections of Novotech

• Perform internal and external audits of investigator sites, vendors, data management, protocols, clinical study reports, internal processes and systems, pharmacovigilance, mock inspections, etc.

• Ensure that audit results are formally recorded and reported in a timely manner and that corrective / preventive actions are implemented effectively

• Participate in the investigation and evaluation of quality events, incidents and follow-up activities

• Evaluation and management of third-party vendors for clinical trial services

• Review and approval of documentation for computerised system validation at Novotech

• Provide GCP and QA advice and training to Novotech personnel

• Develop and review written procedures and other documents for the Novotech QMS

• Generate and provide metrics, status and trend reports and other information, as required by management

• Attend client calls and meetings representing the QA department

• Maintain an up-to-date knowledge of appropriate national and international GCP legislation and guidelines that affect the business

Experience and Qualifications: