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:
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.
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, incidents and follow-up activities
Evaluation and management of third-party vendors for clinical trial services
Review and approval of documentation for computerised system validation at Novotech
Provide GCP and QA advice and training to Novotech personnel
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
Attend client calls and meetings representing the QA department
Maintain an up-to-date knowledge of appropriate national and international GCP legislation and guidelines that affect the business
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 positive ability to interpret, understand and apply GCP in ‘challenging’ situations.
Robust customer focus, excellent communication and interpersonal skills and the ability to multi-task and function independently as required.
Novotech is proud to offer a excellent workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated f

📌 Quality Assurance Auditor Ii Bengaluru
🏢 Novotech Global
📍 Bengaluru