Quality Assurance Executive

Graduate and above

All genders

6 days working | Day Shift

Job Benefits: Insurance, PF

• Involve in all quality-related activities within the manufacturing facility.
• Review and approve all quality-related documents, procedures, standards, and specifications that impact product quality, including protocols, reports, master documents, etc., ensuring completeness, consistency, and accuracy of CGMP data.
• Release or reject all starting materials, intermediates, and finished products based on established systems and criteria.
• Establish systems for releasing or rejecting starting materials, finished products, raw materials, intermediates, packaging, labeling materials, etc.
• Review completed batch production and quality control records of critical process steps before releasing finished products for distribution.
• Ensure thorough investigation and appropriate action for any errors or deviations, approving investigations, deviations, and related documentation.
• Review logbooks and provide guidance for identifying root causes and opportunities for quality system improvements.
• Prepare, review, and approve master documents.
• Ensure internal audits (self-inspections) are conducted.
• Approve changes that potentially impact intermediate or finished product quality.
• Review and approve qualification and validation protocols and reports.
• Investigate and approve conclusions related to quality complaints.
• Ensure critical equipment is maintained, calibrated, and tested appropriately.
• Monitor and ensure progress on corrective and preventive actions (CAPA).
• Conduct product quality reviews for abnormal observations, data trends, and related investigations.
• Ensure department, premises, and equipment are qualified and maintained.
• Ensure procedures and specifications are appropriate and followed by contractors performing activities impacting product quality, such as manufacturing, packaging, testing, calibration.
• Notify senior quality management of critical non-conformances or incidents.
• Oversee initial and ongoing training of department personnel, approving CGMP training requirements.