Responsibilities
1. Planning and hosting of client audits and/or regulatory inspections of Novotech.
2. Perform audits of investigator sites, vendors, Trial Master Files, internal processes and systems.
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, root cause analysis, CAPA plan and follow-up activities.
5. Evaluation of third-party vendors for clinical trial services.
6. Review and approval of GxP computerised system validation documents.
7. Ensure QA tracking systems are up to date
8. Provide GCP and QA advice and training
9. Develop and review written procedures and other documents for the Novotech QMS
10. Generate and provide metrics, status and trend reports and other information, as required by management.
11. Liaise with client, vendors and internal operational staff on quality aspects.
12. 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
Novotech is a global full-service clinical Contract Research Organization (CRO).
At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do.
Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.
With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.
At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.
At Novotech you will work alongside empowered teams with a shared commitment to success.
- Strategic vs transactional mindset.
- Ability to gain insights and make proactive decisions quickly.
- Culture that fosters partnership and collaboration, where every voice is heard and valued.
- Ongoing support from senior stakeholders and leadership team.
Novotech Melbourne, Victoria, AUS Office
Melbourne, Australia
