Quality Assurance Specialist

Job Description

We are looking for a Quality Assurance Specialist to join our Compliance team. The successful candidate will be responsible for establishing quality systems, ensuring compliance with regulatory requirements, and contributing to continuous quality improvement initiatives across the organization.

Key Responsibilities:

• Manage product quality complaints and collaborate with other relevant departments to ensure timely follow-up and resolution. 
• Support the implementation, monitoring, and effectiveness evaluation of CAPA (Corrective Action/Preventive Action) processes. 
• Prepare, review, and maintain quality documentation in compliance with internal procedures and regulatory requirements. 
• Develop, revise, and manage Standard Operating Procedures (SOPs) and related quality documents, while monitoring SOP updates in other departments.
• Conduct quality investigations, root cause analyses, and risk assessments. 
• Coordinate with internal stakeholders on all quality-related matters. 
• Ensure proper document control, archiving, and record management systems. 
• Participate in internal audits, compliance activities, and continuous improvement projects. 
• Support pharmacovigilance and adverse drug event-related quality processes. 

Requirements:

• At least a Bachelor's degree in related fields. 
• At least 2 years of experience in Quality Assurance, Compliance, Quality Systems, or related pharmaceutical functions. 
• Strong communication and stakeholder management skills. 
• Experience in SOP writing, document management, and quality documentation practices. 
• Familiarity with pharmaceutical regulations, quality management systems, and experience interacting with regulatory bodies or healthcare authorities is considered an advantage. 
• Proficiency in Microsoft Office applications. 
• Upper-intermediate level of English.