Job Details
Job Ref: 212470660
Date: 2020-09-21 14:54:27
We are recruiting for a Quality Control Speacialist for our client who are a global pharmaceutical company.
The main purpose of the role is to support activities in the areas of production and qualification of critical reagents (biomaterials) used in Bio-assays, such as ELISA coats, ELISA conjugates, reference toxins etc. Also to support analytical method validation and method transfers between labs.
Key accountabilities
* Validation – ability to work on several projects simultaneously and be able to prioritise. Reporting and communication of results to stakeholders. Liaise with several departments – technical support groups, QA, Regulatory to drive project completion and deliver on milestones.
* Validation of biomaterials used in in-process and final product testing. This will include technical writing of protocols, testing and execution of protocols and writing final reports.
* Method validation and test transfer between labs/sites.
* Expertise in Immunology techniques such as ELISA’s, haemagglutination tests, antigen mass assay is essential.
* Good understanding and ability to perform efficient lab investigations arising from deviations or invalid/atypical results.
Knowledge & Experience
* Good understanding and working knowledge of GMP Quality Systems
* Technical expertise in ELISA’s and other immunology techniques
* Minimum 2 years of experience with excellent understanding of testing within a laboratory environment
* Laboratory investigations
* Validation and method development
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