Description

Job Description

Role Summary The Quality Assurance Specialist is responsible for ensuring that all required information and documentation are properly reviewed, evaluated, and approved to confirm that pharmaceutical products meet the intended quality standards and regulatory requirements. The role involves coordinating and controlling quality-related activities in compliance with approved procedures, Pharmaceutical Quality Systems, and SFDA regulation

Responsibilities

• 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.