Job Reference: J5635048
Updated On: 08/06/2021
Status: Open to Applications
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Role OverviewWe are currently looking for a QC Method Validation Manager to join a leading Gene Therapy company based in the London area. As the QC Method Validation Manager you will be responsible for the validation and technology transfer of novel and established test methods for the analysis of gene therapy products and associated materials used for manufacturing the EU and FDA GMP requirements.
Key Duties and ResponsibilitiesYour duties as the QC Method Validation Manager will be varied however the key duties and responsibilities are as follows:
1. You will serve as the SME for lifecycle management of analytical assays, equipment and materials including in-process samples and finished products.
2. As the QC Method Validation Manager you will generate qualification/validation projects and associated documentation in support of the analytical activities performed ensuring compliance requirements are maintained.
3. You will also support the set up of the QC department for the continuation of the analytical testing for clinical trial materials, commercial supply and stability studies.
4.The QC Method Validation Manager will also be responsible for ensuring all training is undertaken in a timely manner as required to perform required activities. You will also support any training activities of other employees where required,
Role RequirementsTo be successful in your application to this exciting opportunity as the QC Method Validation Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in Life Sciences related discipline plus industry experience.
2. Proven industry experience in an analytical development and validation role in the pharmaceutical or other regulated industry.
3. A working knowledge and practical experience working towards GMP regulations.
Key Words: QC / Quality Control / Validation / Method Validation / GMP / Good Manufacturing Practice / Manager / Life Sciences / Gene Therapy / Biopharmaceuticals / Analytical.
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