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

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

- 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.
- 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
- Provide GCP and QA advice and training to Novotech personnel
- Develop and review written procedures and other documents for the Novotech QMS
- Attend client calls and meetings representing the QA department

# 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. 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. 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 cooperative culture, whilst working with clients on the cutting-edge of life sciences.

📌 Quality Assurance Auditor-Maternity Cover (India)
🏢 Novo Tech
📍 India