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Senior Specialist Quality Assurance
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General
💰 Salary Not shared
📊 Market S$6,500–S$9,500/mo (S$78,000–S$114,000/yr)
About the Company
AstraZeneca is building its first biologics manufacturing campus in Singapore - a groundbreaking USD 1.5 billion investment that will serve as a global hub for innovation and excellence. The campus will be equipped with innovative digital and automation infrastructure, enabling autonomous manufacturing powered by artificial intelligence. In addition, it will be designed for carbon neutrality, embedding sustainability into every aspect of operations and setting a new benchmark for environmentally responsible biologic's manufacturing.
About the Role
Are you ready to help build world-class Quality Assurance capability from the ground up at a first-of-its-kind biologics campus in Singapore This is a rare opportunity to shape the standards, systems and culture that will bring life-changing medicines to patients faster and more reliably. As Senior Specialist Quality Assurance, you will provide end-to-end QA oversight across one or more facilities within our new campus, spanning raw materials, biologics and small-molecule intermediates, conjugation, sterile filling and lyophilization, packaging, QC and warehousing.
Responsibilities
- ● Guide execution of core quality processes across internal manufacturing and control, including local supplier quality, ensuring timely, accurate documentation and data integrity to enable confident batch release and flow of materials.
- ● Provide direct, daily QA oversight in manufacturing suites, labs and support areas to ensure activities align with cGMP, approved procedures and the site pharmaceutical quality system.
- ● Review and approve investigations, establish true root causes, define and track effective CAPAs, and verify sustained effectiveness to reduce recurrence and improve process capability.
- ● Review and approve qualification and validation results, changes within the change management framework, QA release, product quality reviews, periodic reports and related documentation.
- ● Advise on GxP expectations, coordinate regulatory documents and referrals, and actively participate in audits, inspections and health authority interactions to maintain a state of control.
- ● Support local supplier management to ensure materials and services meet specifications and compliance requirements, highlighting and resolving issues with urgency.
- ● Conduct data analysis and develop clear reports and insights on quality metrics and benchmarks using digital tools; translate trends into actions that improve compliance, flow and reliability.
- ● Benchmark internal and external best practices for quality and compliance, identifying areas for improvement and implementing changes to maintain a competitive edge.
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