Junior Quality Associate

As a Junior Quality Associate, you will play a crucial role within the Quality Team of the Pharmaceutical Affairs Department at Aspen Global Incorporated (AGI). This role supports the Compliance, Quality, and Regulatory teams, ensuring that the products supplied to various markets are compliant with registered details. You will assist Quality Managers in executing administrative tasks related to quality management, including handling deviations, customer complaints, and change controls. Your primary responsibility is to ensure that AGI’s suppliers adhere to Good Manufacturing Practices (GMPs) and maintain the highest quality standards.

Key Responsibilities

• Product Compliance
• Ensure that products supplied to markets meet registered specifications, including shelf-life, storage conditions, and other relevant details.
• Liaise with the Regulatory Team and Affiliates to confirm registered product details and prepare necessary compliance documentation.
• Monitor regulatory approvals and communicate updates to manufacturing sites for timely implementation.
• Supplier Qualification & Documentation
• Maintain up-to-date documentation for suppliers, including technical agreements, product quality reviews, stability reports, and quality statements.
• Review documentation received from manufacturing sites and update relevant trackers (e.g., Product Quality Reviews, Stability Data).
• Liaise with manufacturing sites to address quality-related issues and monitor the completion of Corrective and Preventive Actions (CAPA) related to Aspen audits.
• Quality Interface
• Serve as the key interface between manufacturing sites, distributors, affiliates, and other AGI departments for quality-related matters.
• Coordinate the investigation of customer complaints with suppliers, log them into the system, and provide responses to the complainant.
• Manage change controls and requests from manufacturing sites, log them into the system, and monitor the completion of associated tasks.
• Handle deviations raised by manufacturing sites, assess their impact on the product, supply continuity, and registered details, and log them into the system.
• Assist during internal and external audits/inspections, ensuring compliance with all quality standards.
• Quality Management System Enhancement
• Identify opportunities for process improvement within AGI’s Quality Management System and support the implementation of these enhancements.

• Bachelor’s or Postgraduate degree in Chemistry, Pharmacy, or a related Science field.
• 1 year of experience in a Quality Control or Quality Assurance environment is a plus. 
• Previous exposure to a pharmaceutical manufacturing site would be a plus.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint) at an intermediate to advanced level.

What's in it for You?

We have established a reputable business in just over a decade and as we continue to grow we remain committed to your personal & professional development. You will be entering a challenging & rewarding environment and a culture where courage, learning, intrapreneurship, fun and wellbeing are central. AGI is proud to offer a competitive total rewards system that continue to make us a desirable workplace.