Senior Quality Assurance Analyst
Há 1 mês
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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