Aurigene is a specialized biotech company, focused on oncology and inflammatory diseases. Aurigene has deep target and therapeutic area expertise, gained from the experience of multiple programs reaching global clinical development from its efforts.
Post : Executive / Sr. Executive
Qualification : M.Pharm / D.Pharm (Pharmacology / Quality Assurance) with 4-6 years' experience Assurance
Department : Development Quality Assurance (Clinical Quality Assurance)
Key Responsibilities :
• Conduct audits of clinical trial documents, including Investigator's brochure, clinical protocols, and Clinical Study Reports, Case Report Forms, and informed consent forms.
• Ensure all processes contributing to the performance of clinical trial are conducted as per local and global regulations.
• Ensure clinical trials are performed in accordance with applicable study protocols and in compliance with GCP guidelines.
• Performing audits of basic records and reports and inspections of routine processes to assure compliance with applicable regulatory requirements, international standards and procedures.
• Prepare, implement systems SOPs and other quality documents to ensure compliance to GCP regulatory requirements.
• Evaluate quality events, incidents, queries, CAPA and complaints of clinical studies and quality trending reports.
• Ensure that investigator, vendor, facility, and system audits are conducted.
• Review study reports and protocols, test methods, data and reports through collaboration with clinical teams, to achieve the highest quality from technical and compliance perspectives.
Job Location : Bangalore
Interested candidates may send their updated resumes with subject line Internal Application for Executive/Sr. Executive- Development Quality Assurance (Clinical Quality Assurance) to Ishita_m@aurigene.com
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