Lead Clinical QA

2 weeks ago

Hyderabad, Telangana, India Dr Reddy's Laboratories Limited Full time
Job Summary

We are looking for a professional to lead the development and management of quality systems in clinical development. As part of this role, you will be involved in strategic planning, audits, ensuring compliance with industry standards, and driving quality assurance initiatives.

Your expertise will be crucial in upholding high-quality standards and compliance in clinical development.

Roles & Responsibilities
  • Develop a global risk-based audit strategy for clinical trials, conduct audits of sites, organizations, and sponsors, review protocols and reports, oversee external audits, and report findings.
  • Review and approve corrective and preventive action plans, ensure regulatory compliance, create metrics for management, and prepare for Health Authority inspections.
  • Maintain quality issue database, conduct audit metrics, support root cause analysis, develop SOPs, and oversee vendor management and training.
  • Assist in Data Management System implementation, manage controlled documents, and oversee archive processes.


Qualifications

Educational Qualification: Bachelor/Master's degree in a relevant scientific field.

Minimum Work Experience: 4-7 years in clinical trial audits, pharmacovigilance audits, and QMS development.



Skills & Attributes
  • Understanding of drug development processes, technology platforms, quality management, and global regulatory requirements.
  • Strong negotiation skills, objectivity, and ability to work in a dynamic environment.
  • Ability to align teams and ensure successful implementation.


About the Department - Biologics

The department operates in the Global Biosimilars business with a robust portfolio of products and a strong track record in developing and commercializing biosimilar products.

They have expertise in manufacturing across technology platforms, maintaining global quality standards, and commercializing biosimilars in multiple markets.


Benefits Offered

Dr. Reddy's provides career growth opportunities, learning programs, family support, medical coverage, and more.


Our Work Culture

Dr. Reddy's employees are driven by the belief that Good Health Can't Wait. They strive to provide healthcare solutions that empower individuals to lead healthier lives.

The company fosters a culture of empathy, dynamism, teamwork, and shared success.

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