Quality Assurance Auditor II

About the Role:

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

Responsibilities: 

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

• 2. 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.

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

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

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

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

• 7. Provide GCP and QA advice and training to Novotech personnel

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

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

• 10. Attend client calls and meetings representing the QA department

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

• 12. Any other activities as required.

Experience and Qualifications:

• Tertiary qualifications in a health science and/or related field.  

• At least 3 ears audit experience in the research/pharmaceutical/CRO industry with a good ability to interpret, understand and apply GCP in ‘challenging’ situations.  

  Strong customer focus, excellent communication and interpersonal skills and the ability to multi-task and function independently as required.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.