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Quality Risk Management Lead
3 months ago
We are currently looking for a Quality Control and Analytical Development Lead to join a leading advanced therapy company based in London.
As the Quality Control and Analytical Development Lead you will craft and oversee the quality control and analytical development functions at our client's cutting-edge pilot plant.
Your role is crucial in ensuring the safety and conformity of the entire production process, collaborating with a skilled team of food scientists, biologists, and engineers.
Your duties as the Quality Control and Analytical Development Lead will be varied however the key duties and responsibilities are as follows:Establish and direct the strategic vision for quality control, creating robust workflows to meet stringent standards.
Oversee the in-house QC lab, liaise with external testing labs, and coordinate with satellite QC labs at manufacturing sites, ensuring clear communication of results to stakeholders.
Collaborate with the Facilities and Laboratories team to implement a top-tier quality management system, authoring risk assessments, SOPs and managing essential quality documentation.
A PhD in cell biology, microbiology, biochemistry, or proven industry experience in a GLP/GMP cell culture production environment.
Extensive experience in quality management, QC/QA, or CMC related to cell culture processes as well as high levels of proficiency in writing quality documentation and reports for regulated products, with a knack for constructing key quality and regulatory plans.
Key Words:
Quality Control / Analytical Development / Food Science / Biotechnology / GLP / GMP / Cell Culture / Quality Assurance / Regulatory Submission / SOPs / HACCP / ISO 9001 / ELISA / Mass Spectrometry / London
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