Quality Assurance Analyst

Role Overview

• 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

Requirements

• 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

Benefits

• Salary appropriate to the functions performed
• High career prospects