Job title - QA Head(sun pharma)

Experience:20+ years

Qualifications: B.pharmacy /M.pharmacy

Job profile:

The Quality Assurance Manager is responsible for defining and executing the operational strategy for Quality Assurance (QA) at the site, aligning with Sun Pharma’s compliance, product quality objectives, and regulatory standards. Key responsibilities include:

1. Strategic Leadership:

   • Define and implement QA strategies to meet business and regulatory goals.

   • Lead site QA activities, ensuring smooth operations and adherence to cGMP requirements.

2. Batch Disposition & Compliance:

   • Oversee batch disposition, ensuring timely release of safe and effective drug products.

   • Ensure compliance with GXP requirements, managing resources and manpower.

3. Continuous Improvement:

   • Identify opportunities to enhance QA systems and processes.

   • Lead corrective actions for audit findings and industry issues.

4. Performance Management:

   • Provide coaching, performance feedback, and training to QA staff.

   • Conduct annual performance reviews and manage consistent performance across the team.

5. Regulatory Inspections & Audits:

   • Prepare for regulatory agency inspections and internal audits.

   • Facilitate corrective actions based on audit findings.

6. Quality Systems Oversight:

   • Ensure compliance with all quality-related SOPs, policies, and standards.

   • Manage investigations for market complaints, failures, and deviations, ensuring timely implementation of corrective actions.

7. Change Control & Risk Management:

   • Oversee the change control and quality risk management processes at the site.

This role ensures the achievement of QA goals through strong leadership, continuous improvement, and strict adherence to regulatory and safety requirements.