Amgen Specialist QA in Singapore, Singapore
Responsible for providing oversight and leadership for Quality on-the-floor and operations support, the Specialist QA will support manufacturing operations and IPC testing through purposeful presence on the floor, and support of complex investigations, change controls, and unexpected result investigations. This role will be required to support rotating shift work (day/night).
Provide direct Quality Assurance support for all GMP activities (including on-the-floor quality oversight, raw materials release, nonconformances, change control and CAPAs) at ASM
Support routine GMP documentation review activities (e.g. electronic batch records, SOPs, logbooks, work orders, batch production reports and validation protocols etc.) and ensure key performance indicator met targeted metrics
Perform comprehensive Quality review to support lot disposition of bulk drug substance
Act as one of the key Quality Contacts to resolve complex issues, adhering to Amgen policies and standards
Participate in root cause investigations for complex and significant nonconformances, leveraging various root cause analysis tools
Mentor and coach cross functional team members in order to establish a quality culture for routine operations
Participate in New Product Introduction (NPI) team to ensure robustness of product changeover as well as cross contamination controls are in place
Participate in regulatory inspections, and interact directly with regulatory inspectors
Lead and support site/network driven QA continuous improvement initiatives/activities (e.g. supplier quality, stability program, product quality review, customer complaint investigation)
Escalate significant quality issues to Quality management in a timely manner
Act as delegate to Plant Quality Assurance (PQA) Shift Manager to support business needs
Doctorate degree in Science and 2 years of directly related experience
Master's degree in Science and 5 years of directly related experience
Undergraduate degree in Science and 8 years of directly related experience
Undergraduate diploma in Science and 10 years of directly related experience
Fluency in written and spoken English
8 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems.
Direct experience with bulk manufacturing of biopharmaceuticals preferred.
Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff