Analytical Method Developer
4 days ago
Our organization seeks a highly skilled QC Validation Specialist to play a pivotal role in the development and validation of cutting-edge analytical test methods for gene therapy products.
Key Responsibilities- Develop comprehensive validation protocols, analyze data, and create detailed reports to ensure compliance with regulatory standards and maintain data integrity.
- Guarantee that all validated methods are seamlessly transferred to quality control (QC) labs, adhering to strict regulatory guidelines and data integrity requirements.
- Effectively communicate with key stakeholders, ensuring timely dissemination of information and maintaining up-to-date documentation folders.
- Regularly assess and evaluate analytical methods used to guarantee their proper application and optimal performance.
- A degree or master's in human health sciences or a related field, accompanied by 2 years of work experience in the pharmaceutical industry or other regulated sectors.
- Demonstrated expertise in analytical methods/validation roles within the research or pharmaceutical industries.
- Proficiency in ICH Q2 (R1) guidelines and proficiency in IT and Microsoft Office software is preferred.
The ideal candidate will be responsible for ensuring their work aligns with Good Manufacturing Practices (GMP), Data Integrity, and Good Documentation Practice (GDP), as well as adhering to applicable procedures.
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Gene Therapy Method Validation Expert
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Shannon, Ireland beBeeValidation Full time €50,000 - €80,000Validation Lead SpecialistWe 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 ResponsibilitiesDevelop and...
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1 week ago
Shannon, Ireland beBeeAnalytical Full time €67,000 - €87,000Job SummaryThe Quality Assurance Validation Specialist plays a crucial role in ensuring the accuracy and reliability of our gene therapy products. This position requires an individual with expertise in analytical method development, validation, and technology transfer.Main ResponsibilitiesDevelop and validate analytical test methods for gene therapy...
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QC Validation Expert
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Shannon, Ireland beBeeValidation Full time €60,000 - €80,000Job Title: QC Validation Specialist">Job Description:">The QC Validation Specialist plays a pivotal role in ensuring the accuracy and reliability of our analytical methods. This specialist is responsible for validating and transferring novel and established test methods for gene therapy products, adhering to EU and FDA GMP requirements.">Main...
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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 analytical...
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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 analytical...
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Qc Validation Specialist
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Shannon, Ireland Hobson Prior Full timeOverviewTechnical Operations & R&D Recruiter | Life Sciences Talent Partner Across EuropeProclinical is seeking a QC Validation Specialist to lead the validation of test methods and ensure compliance with EU and FDA GMP standards, contributing to the development of cutting-edge analytical techniques.Please note that to be considered for this role you must...
