Aurigene is a development stage biotech company engaged in discovery and clinical development of novel and best-in-class therapies to treat cancer and inflammatory diseases, and a wholly owned subsidiary of Dr Reddy’s Laboratories Ltd. Aurigene is focused on precision - oncology and has multiple compounds at different stages of pre-clinical development and several products in pipeline in clinical development.
Post : Assistant Manager - Clinical Quality Assurance
Desired Skills : M.Pharm / D.Pharma / M.Sc (Pharmacology / Pharmaceutics / Quality Assurance) with 8-14 years' experience
Location : Bangalore
Roles & Responsibilities
• Ensure that all processes contributing to the performance of clinical trial are conducted as per local and global regulations
• Responsible for audits of clinical trial documents, including Investigator's brochure, clinical protocols. Clinical Study Reports, Case Report Forms, and informed consent forms through collaboration with clinical teams, to achieve the highest quality from technical and compliance perspectives
• Responsible for the assurance of clinical trials performed in accordance with applicable study protocols and in compliance with GCP guidelines
• Perform audits of clinical trial sites
• Perform TMF / eTMF audits
• Prepare, implement SOPs and other quality documents to ensure compliance to GCP and Organizational requirements
• Evaluate quality events, incidents, queries, CAPA and complaints of clinical studies and quality trending reports
• Responsible for review and compilation of clinical modules for dossier submissions.
• Audit of applicable vendors
Send your resume at ishita_m@aurigene.com
Last Date : 30th May, 2023
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