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Quality Assurance Manager

2 weeks ago

Hyderabad, Telangana, India Novartis Full time

About the Role

We are seeking a highly skilled Quality Assurance Manager - Pharmaceutical Operations to join our team at Novartis. This is an exciting opportunity for a motivated and experienced professional to contribute to the success of our organization.

Job Summary

The Quality Assurance Manager - Pharmaceutical Operations will be responsible for ensuring compliance with cGMP requirements and Sandoz Quality Management System as defined and agreed between GQSI and business partners. Key responsibilities include managing quality aspects, projects within area of responsibility, adhering to current GxP and compliance requirements, performing and delivering quality operations in support of product quality compliance and regulatory workflows.

Key Responsibilities

  • Develop and implement quality systems and processes to ensure compliance with regulatory requirements.
  • Manage quality projects and initiatives to improve quality performance and reduce risk.
  • Develop and maintain quality documentation, including SOPs, training programs, and quality metrics.
  • Analyze quality data and identify trends and areas for improvement.
  • Collaborate with cross-functional teams to resolve quality issues and implement corrective actions.
  • Communicate quality information and metrics to stakeholders, including senior leadership and external auditors.
  • Lead audits and inspections, including preparation, execution, and follow-up activities.
  • Develop and manage quality budgets and resources to ensure effective use of resources.
  • Stay up-to-date with regulatory requirements and industry best practices to ensure continuous improvement of quality systems and processes.