Responsibilities
- Planning and hosting of client audits and/or regulatory inspections of Novotech.
- Perform audits of investigator sites, vendors, Trial Master Files, internal processes and systems.
- 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, root cause analysis, CAPA plan and follow-up activities.
- Evaluation of third-party vendors for clinical trial services.
- Review and approval of GxP computerised system validation documents.
- Ensure QA tracking systems are up to date
- Provide GCP and QA advice and training
- 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.
- Liaise with client, vendors and internal operational staff on quality aspects.
- Maintain an up to date knowledge of appropriate national and international GCP legislation and guidelines that affect the business.
Minimum Qualifications & Experience
- Tertiary qualifications in life science and/or related field.
- For Quality Assurance Auditor II, at least one year previous experience in QA or GCP field
- For Quality Assurance Auditor III, at least two years previous experience in GCP QA
- For Senior Quality Assurance Auditor, at least three years previous experience in GCP QA and is able to perform audits independently.
- Strong customer focus, attention to detail, excellent communication and interpersonal skills and the ability to multi-task and function independently as required.
- Good English proficiency
Job description provided by Novotech.
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