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Sterile Injectables Specialist

1 week ago

Singapore Thermo Fisher Scientific Full time
Job Summary:

We are looking for a highly motivated and detail-oriented Sterile Injectables Specialist to join our team at Thermo Fisher Scientific. In this role, you will be responsible for supporting the production of commercial sterile injectable drugs and packaging/visual inspection activities.

Your primary focus will be on providing technical expertise for quality compliance activities, including documentation updates to batch records, SOPs, risk assessments, change control, investigations, and CAPA. You will work closely with the manufacturing team to identify problem causes, make process changes, and implement new production technologies.

Additionally, you will assist with day-to-day production tasks, including analysis and adjustment of process parameters, critical quality attributes (CQAs), and equipment performance using statistical tools during CPV and APR. Your expertise in technical writing skills will enable you to author technical or validation protocols, reports, and other documentation related to existing products or NPI at the site.

To succeed in this role, you will need strong understanding of pharmaceutical manufacturing processes, GMP, and Statistical Process Controls. You should also have good computer skills and familiarity with laws and regulations relating to safety and environmental conservation.