Aurigene Job Vacancy for Development Quality Assurance Department

Aurigene Job Vacancy for Development Quality Assurance Department

We are looking for you!

Position: Executive/Sr. Executive

Department: Development Quality

Assurance (Clinical Quality Assurance)

Qualification: M. Pharm/D. Pharm (Pharmacology/ Quality Assurance) with 4-6 years' experience

Job Location: Bangalore

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.

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 

For queries, please contact: +91-9454467321

Aurigene Job Vacancy for Development Quality Assurance Department