External Quality Operations Manager

📋 Description

• Perform as EQOM to act as Single point of contact for all quality related activities at the
• Ensure that all aspects of handling, manufacturing, distribution of products are in compliance with
• Support the products release by acting as QP Delegate according to delegation documents, when
• Support the External Service Provider (CMO) Qualification
• Ensure Quality Technical Agreement (QTA) be established appropriately and ensure valid QTA clearly
• Ensure implementation and maintaining Quality Risk Assessment and KPIs on Quality External

🎯 Requirements

• High level education (university degree or similar) within relevant area such as pharmaceutical
• More than 5 years of experience within pharmaceutical, biotech product. Experience in QA operation
• More than 1 years of managing external quality oversight of CMOs
• Curriculum is requested for evaluating the batch release qualification requirement
• Fluently spoken and written English

🎁 Benefits

• Opportunities for professional growth
• Competitive compensation for your work
• Diversity and Inclusion
• A flexible workplace that supports work-life balance