Amgen Senior Associate Quality Assurance in Singapore, Singapore
Quality Professional with background and experience in commercial production of Biological drug substance to oversee night shift operations.
Conduct Quality Assurance activities related to quality floor support for solution and equipment prepartation, cell culture and product purification & Drug Substance Filling operations.
Support of electronic batch record review and approval, change control, investigations and product release
Work in a cross functional team with Process Development, Manufacturing, Supply Chain, Engineering and Facilities to ensure product quality and market supply
Role may include participation in new product introductions, additional equipment, installation commissioning, qualification.
Support continuous improvent initiatives
Education / Licenses
Degree in Chemistry, Chemical Engineering Science or related technological field
Doctorate degree & 2 years of directly related experience OR
Master’s degree & 2 years of directly related experience OR
Bachelor’s degree & 5 years of directly related experience
- 4-6+ years of relevant work experience in the commercial manufacturing environment within the pharmaceutical industry
Competencies / Skills
Must have experience and understanding of GMP pharmaceutical production, biological drug substance experiance and operation preferred
Experience with batch record review, and quality record support
Experience in pharmaceutical equipment operation, design and control including GMP change control
Experience in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production
Understanding of equipment log review and continuous monitoring requirements
Good communication skills (technical writing and verbal communication/presentation)
Interacts effectively with variety of communication and working styles
Experience with regulatory audits and inspections
Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality
- Work on shift schedules will be required
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.