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:

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- Assist and lead (as applicable) with the planning and hosting of client audits and/or regulatory inspections of Novotech

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- Participate and lead (as applicable) internal and external audits of investigator sites, vendors, data management, protocols, clinical study reports, internal processes and systems, pharmacovigilance, mock inspections, etc.

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

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

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

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

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- Provide GCP and QA advice and training to Novotech personnel

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

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

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- Attend client calls and meetings representing the QA department

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

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- Any other activities as required.