Senior Executive Quality Assurance

Role Summary

• Batch Record Audit & Release

• Receive, review, audit, and verify batch record documentation.
• Ensure all batch records are complete, accurate, and compliant with approved procedures and GMP requirements.
• Identify incomplete data, discrepancies, or calculation errors and coordinate corrections with concerned departments.
• Verify that all OOS, deviations, NCMRs, and change requests related to the batch are properly documented, investigated, and closed.
• Review batch yield and accountability records.
• Document audit findings and follow up on corrective actions.
• Report deviations identified during batch record audits.
• Release finished goods batches in accordance with SFDA requirements.
• Submit completed batch records to Document Control for proper archiving.

• Regulatory & Compliance Activities

• Manage activities related to controlled drug handling in compliance with SFDA guidelines, including importation, clearance, manufacturing, transfer, destruction requests, and reconciliation activities.
• Maintain and update records of product registration certificates issued by SFDA.
• Maintain and update SFDA-regulated product price lists.
• Ensure compliance with applicable SOPs and maintain updated process-related logbooks.

• Coordination & Communication

• Communicate audit findings and quality-related issues with cross-functional departments.
• Coordinate with internal stakeholders to ensure timely resolution of quality observations and documentation gaps.
• Support continuous compliance with Pharmaceutical Quality Systems and regulatory standards.

Qualifications & Skills

• Bachelor’s Degree in Pharmacy.
• Minimum of 2 years of experience in a similar Quality Assurance role within the pharmaceutical industry.
• Good understanding of Pharmaceutical Quality Systems and GMP requirements.
• Knowledge of SFDA regulations and compliance requirements.
• Strong interpersonal and communication skills.
• Proficiency in Microsoft Office and ERP systems.
• Fluent in English.