Quality Assurance Executive

Key Responsibilities

• Ensure compliance with cGMP, regulatory guidelines, and company quality standards.
• Review and approve:
• Batch Manufacturing Records (BMRs)
• Batch Packing Records (BPRs)
• Standard Operating Procedures (SOPs)
• Protocols and reports (validation, qualification, etc.)
• Monitor shop floor activities to ensure adherence to approved procedures.
• Handle deviations, incidents, Out-of-Specification (OOS), and Out-of-Trend (OOT) investigations.
• Participate in root cause analysis and implementation of CAPA (Corrective and Preventive Actions).
• Conduct internal audits and support external audits (regulatory and customer).
• Review and manage change control documentation.
• Ensure proper documentation practices (GDP compliance).
• Coordinate with Production, QC, and other departments for quality-related issues.
• Support validation activities (process validation, cleaning validation, equipment qualification).
• Ensure data integrity and compliance with ALCOA+ principles.
• Maintain QA documentation and archival systems.