Quality Engineer at EDAP TMS supporting the quality management system and continuous improvement initiatives. Collaborating on projects and conducting audits to ensure quality standards are met.
About the role
- Analyst in Quality Assurance focusing on pharmaceutical product testing and ensuring compliance with regulations. Conducting various tests and inspections during the production process.
Responsibilities
- Perform the analysis of the in-process control testing’s
- Sample the vials to be tested by the Sterility assurance and Quality Control Departments during production of each batch
- Sample and prepares finished product samples for stability testing, whenever requested
- Perform routine round checks in all departments
- Approval all the canisters and sterbags of raw material that are delivered to production
- Perform inspections in the production areas whenever necessary
- Carries out the start-up before the beginning or during production
- Conduct the personnel behavior to sterile core program
- Sample and carries out acceptance procedures in all the different phases of the production and packaging process, and undertakes visual inspection by attributes
- Sample, handle, archive, record and follow up on finished product reserve samples
- Reject raw material and components delivered by production or packaging departments
- Approve maintenance requisitions on the X3 for the release of production
- Follows the shipping of all the products manufactured and/or packed in Hikma 2 Plant
- Perform acceptance of the Returns from the Market
- Define the proper corrective measures of each event related with weight deviations
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
Benefits
- Direct contract with Hikma
- Life insurance
- Health insurance
- Annual Performance Bonus
- High career prospects
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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