Gene Therapy Method Validation Expert
1 day ago
We are seeking a skilled professional to lead the validation of test methods and ensure full compliance with regulatory standards. As a Validation Lead Specialist, you will contribute to the development of cutting-edge analytical techniques and support the maintenance of the Quality Management System.
Key Responsibilities- Develop and validate new and existing test methods for gene therapy products.
- Create and analyze protocols, reports, and data to support method transfer activities.
- Ensure all methods meet regulatory standards and maintain data integrity.
- Write and update standard operating procedures (SOPs) for validated methods.
- Communicate progress and updates on method transfers to stakeholders.
- Regularly review analytical methods to ensure they are functioning as expected.
- Background in human health or sciences, with relevant qualifications.
- Experience in quality control or analytical method validation in a regulated industry.
- Familiarity with techniques such as qPCR, HPLC, ELISA, Western blot, cell culture, and DNA extraction.
- Knowledge of ICH Q2 R1 guidelines and proficiency in Microsoft Office tools.
This is an excellent opportunity for a motivated professional to make a significant contribution to the development of innovative analytical techniques and ensure the highest standards of quality and compliance.
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Analytical Methods Specialist
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Shannon, Ireland beBeeValidation Full timeJob Title: QC Validation SpecialistOverviewThe QC Validation Specialist is responsible for ensuring the quality and integrity of analytical methods used in the production of gene therapy products. This includes validating and transferring test methods to ensure compliance with regulatory standards such as EU and FDA GMP requirements.Key...
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Gene Therapy Production Specialist
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Validation Specialist Position
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Qc Validation Specialist
1 day ago
Shannon, Ireland Hobson Prior International Ltd Full timeOverviewSkilled and dedicated in engineering?Looking for a new challenge in Validation?Proclinical is seeking a QC Validation Specialist which is your next perfect roleThis position will be required to lead the validation of test methods and ensure full compliance with EU and FDA GMP standards while contributing to the development of cutting-edge analytical...
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Qc Validation Specialist
1 day ago
Shannon, Ireland Hobson Prior International Ltd Full timeOverviewSkilled and dedicated in engineering?Looking for a new challenge in Validation?Proclinical is seeking a QC Validation Specialist which is your next perfect roleThis position will be required to lead the validation of test methods and ensure full compliance with EU and FDA GMP standards while contributing to the development of cutting-edge analytical...
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QC Validation Specialist
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Shannon, Ireland Hobson Prior International Ltd Full timeOverviewSkilled and dedicated in engineering? Looking for a new challenge in Validation? Proclinical is seeking a QC Validation Specialist which is your next perfect roleThis position will be required to lead the validation of test methods and ensure full compliance with EU and FDA GMP standards while contributing to the development of cutting-edge...
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Gene Therapy Product Specialist
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Shannon, Ireland beBeeManufacturing Full time €40,000 - €50,000Manufacturing Professional","The successful candidate will be responsible for ensuring the quality and compliance of manufactured products in a regulated environment.","Performing manufacturing tasks to produce gene therapy products in accordance with Good Manufacturing Practices (GMP).Maintaining a clean and organized workspace, adhering to high hygiene...
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QC Expert
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Qc Analyst
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Shannon, Ireland Hobson Prior International Ltd Full timeHobson Prior is seeking a QC Analyst to permanently join a biotech organization.In this role, you will play a key part in ensuring quality control processes meet Good Manufacturing Practice (GMP) standards to support the production and release of gene therapy products.This position also involves contributing to the setup of a new GMP facility, including...
