Senior Quality Assurance Analyst

Há 1 mês


Lisboa, Lisboa, Portugal Phiture Tempo inteiro
Quality Assurance Analyst Role Description

We are seeking a highly skilled Quality Assurance Analyst to join our team at Hikma. As a key member of our Quality Assurance Department, you will play a critical role in ensuring the quality and integrity of our pharmaceutical products.

  • Main Responsibilities:
  • Conducting or verifying analysis of bulk samples
  • Verifying or conducting sampling and analysis of the in-process control during filling of batches
  • Conducting or verifying analysis after cleaning of machine production parts to verify clean conformity
  • Ensuring that equipment and solutions in use are maintained under validity
  • Sampling finished product to be tested by the Microbiology and Quality Control Departments
  • Performing round checks in production departments, bulk packaging, and infrastructures
  • Performing inspections in the production areas whenever necessary
  • Carrying out the start-up before the beginning or during production (whenever necessary)
  • Performing Aseptic Practices and Cleaning/Disinfection Monitoring
  • Carrying out acceptance procedures in all the different phases of the production and undertaking visual inspection by attributes for defects
  • Approving maintenance requisitions for the release of production
  • Training new QA analysts

Requirements:

  • High School Diploma or an Academic degree in Science
  • Ability to handle multi-task operations, meet tight deadlines, and work under pressure
  • 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


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