Validation Specialist Position

19 hours ago

Shannon, Ireland beBeeAnalytical Full time €60,000 - €80,000
Job Title:

Analytical Validation Professional

About the Role

We are seeking an experienced analytical validation specialist to proactively contribute to the development of cutting-edge analytical techniques while ensuring full compliance with regulatory standards.

This role involves developing and validating new and existing test methods for gene therapy products, creating and analyzing protocols, reports, and data to support method transfer activities, maintaining data integrity, writing and updating standard operating procedures (SOPs), communicating progress and updates on method transfers to stakeholders, and reviewing analytical methods to ensure they are functioning as expected.

The ideal candidate will have a background in human health or sciences, relevant qualifications, experience in quality control or analytical method validation in a regulated industry, familiarity with various analytical 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.

The successful candidate will possess strong organizational and communication skills, be able to work effectively in a team environment, and demonstrate a commitment to excellence in analytical validation.

Key Responsibilities
  1. Develop and validate new and existing test methods for gene therapy products
  2. Create and analyze protocols, reports, and data to support method transfer activities
  3. Maintain data integrity by ensuring all methods meet regulatory standards
  4. Write and update standard operating procedures (SOPs)
  5. Communicate progress and updates on method transfers to stakeholders
  6. Regularly review analytical methods to ensure they are functioning as expected
Requirements
  1. Background in human health or sciences, with relevant qualifications
  2. Experience in quality control or analytical method validation in a regulated industry
  3. Familiarity with techniques such as qPCR, HPLC, ELISA, Western blot, cell culture, and DNA extraction
  4. Knowledge of ICH Q2 R1 guidelines and proficiency in Microsoft Office tools
  5. Strong organizational and communication skills

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