Analytical Method Validation Specialist

4 weeks ago


St Louis, Missouri, United States Mallinckrodt Pharmaceuticals Full time

Job Title: Analytical Method Validation Specialist

Job Summary:

The Analytical Method Validation Specialist is responsible for conducting comprehensive reviews of analytical methods to ensure compliance with regulatory standards and suitability for intended use. This role is critical in maintaining product quality and minimizing risk associated with analytical processes.

Key Responsibilities:

  • Conduct in-depth reviews of analytical method validation protocols, procedures, and associated data.
  • Assess method performance against established acceptance criteria for parameters such as accuracy, precision, specificity, linearity, range, limit of detection, and limit of quantification.
  • Evaluate method robustness and ensure compliance with relevant regulatory guidelines (e.g., USP, Ph. Eur., ICH).
  • Prepare detailed reviewed reports summarizing findings, conclusions, and recommendations.
  • Participate in closure meetings with stakeholders to discuss review outcomes and gain approval.
  • Maintain accurate and organized documentation of review activities and findings.
  • Collaborate with cross-functional teams to address validation-related issues and implement corrective actions.
  • Stay updated on relevant regulatory requirements and industry best practices.
  • Independently develop project plans and timelines to achieve desired results with minimal oversight.

Requirements:

  • BS in Chemistry, Chemical Engineering, or related science.
  • Minimum of 5 years' of pharmaceutical experience required with prior experience in analytical method validation and quality assurance.
  • Strong understanding of analytical chemistry principles and techniques.
  • Knowledge of pharmaceutical regulations including current GxP, GAMP5, Part 11, and Data Integrity requirements.
  • Knowledge of ICH Q7 and Q11 is required.

Working Conditions:



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