Conducting or verifying analysis of bulk sample
Verifying or conducting sampling and analysis of the in-process control during filling of the batches
Conducting or verifying analysis after cleaning of machine production parts to verify clean conformity
Verify or enter the data of the in-process forms/logbook/LIMS on a daily basis and check for accuracy upon request
Ensures that the equipment's and solutions in use are maintained under validity
Sample finished product to be tested by the Microbiology and Quality Control Departments
Performs round checks in production departments, bulk packaging and infrastructures
Performs inspections in the production areas whenever necessary
Carries out the start-up before the beginning or during production (whenever necessary)
Performs Aseptic Practices and Cleaning/ Disinfection Monitoring Samples and carries out acceptance procedures in all the different phases of the production, undertakes visual inspection by attributes for defects
Approves maintenance requisitions for the release of production
Trains new QA analyst
Verifies print-outs from equipment related with productions activities

High School Diploma or an Academic degree in Science
Ability to handle a multi-task operation, to meet tight deadlines and to work under pressure
Should be assertive, flexible, and attentive to detail
Fluency in English and good computer skills are preferred
Knowledge regarding the Injectables pharmaceutical industry, current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) and other regulatory authority requirements
Availability to work 12-hour shifts with rotating days off

Quality Assurance Analyst – 12H

About this role