My client, a global biopharmaceutical organisation, is looking for a QC Biologist to:
* Support activities in the areas of qualification of critical reagents (biomaterials) used in Bio-assays, such as ELISA coats, ELISA conjugates, reference toxins etc.
* To support analytical method validation / improvements and method transfers for Biology and Microbiology labs between sites.
Key Responsibilities and Duties:
* Expertise in Immunology techniques such as ELISA’s, haemagglutination tests, antigen mass assay is essential.
* Understanding of microbiology techniques is beneficial.
* Validation of biomaterials used in in-process and final product testing.
* Biology/Microbiology method validation / improvements and test transfer between labs/sites.
* Drive change management for introduction of new / improved methods and validation of new equipment.
* Be able to produce technical documents such as protocols, testing and execution plans and final reports.
* 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.
* The candidate will be required to report all laboratory activities in a clear, organised manner, in the form of reports, following the standard operating procedures.
* Good understanding and ability to perform efficient lab investigations arising from deviations or invalid/atypical results.
* The candidate should be able to provide training to staff on test methods and equipment usage.
* Additionally, the candidate may be required to support laboratory investigations, perform troubleshooting exercises and participate in proof of principle studies.
* Reporting and investigation of OOS and OOT results, determine root causes and implementing effective CAPA actions.
* Perform project related literature searches.
* Interact closely with fellow scientists and global/regional colleagues within own and other departments.
* Work in a multi-disciplinary and international team and environment.
The ideal candidate will hold a degree or equivalent in Biology or a related discipline and will have a good understanding and working knowledge of GMP quality systems. You will also have experience in Elisa and other immunological techniques with validation and method development experience
Corrective And Preventive Action (Capa)
Good Manufacturing Practices
Product Quality Assurance
Enzyme Linked Immunosorbent Assay (Elisa)