Amgen Specialist QC (Chemistry) in Singapore, Singapore
Ensure laboratory systems and operations meet GMP compliance and Amgen Quality Management System requirements.
Work in a cross functional team with Process Development, Manufacturing, Supply Chain, Engineering and Facilities to ensure product quality and market supply
Provides technical support to ensure the manufactured products meet the applicable regulatory standards and guideline with respect to Quality Control.
Responsible for planning, scheduling and performing laboratory testing and reviewing of test results on in-coming raw materials, utility water, In-process control, drug substance samples in GMP pharmaceutical environment.
Conduct or lead laboratory investigations and assist in timely closure of investigations, CAPAs and deviations
Support laboratory operations including but not limited to equipment qualification, calibration, cleaning and maintenance, reagent/buffer preparation.
Participates in method verification and method validation/transfer (when required)
Facilitate training of new/ junior laboratory staff and sure all staff are appropriately trainined and qualified to execute the duties assigned to them with respect to the job.
Author of SOP/protocols/reports.
Prepare and support audit. Represent Quality Control function during regulatory inspections.
Lead continuous improvement initiatives and projects.
Any other tasks assigned by the supervisor/QC Manager.
Education / Licenses
Doctorate degree & 2 years of directly related experience OR
Master's degree & 4 years of directly related experience OR
Bachelor's degree & 8 years of directly related experience
- 6-8 years of relevant work experience in the commercial manufacturing environment within the pharmaceutical industry, API production and analytical testing experience preferred.
Competencies / Skills
Demonstrated knowledge and understanding of cGMP, GLP and associated regulatory expectations related to pharmaceutical and associated testing methods.
Demonstrated experience and competency in Quality Control testing and GMP laboratory operations for pharmacopeia testing methods and equipment (HPLC, wet chemistry, Gas Chromatography, Residual Solvents, Liquid Chromatography-Mass Spec, Heavy Metals, Bioburden, Endotoxin)
Demonstrated experience in GMP laboratory operation including development and management of systems for equipment qualification, method validation, sample management, data management, trending and OOS investigations
Demonstrated knowledge and application of sound scientific principles, theories, techniques and skills.
Train and mentor junior laboratory staff
Experience in laboratory assest management, method qualification and transfers
Good communication skills (technical writing and verbal communication/presentation)
Identify, understand and organize daily laboratory work in support of manufacturing operations
Interact effectively with cross functional team
Problem solving skills and troubleshooting 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 may be required