Sample interview questions: Can you discuss your experience with analytical method development and validation?
Sample answer:
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Analytical Method Development:
- Developed and validated analytical methods for active pharmaceutical ingredients (APIs) and impurities in various dosage forms using various analytical techniques, including HPLC, GC, and LC-MS/MS.
- Utilized statistical design of experiments (DoE) to optimize method parameters and achieve desired accuracy, precision, linearity, specificity, and robustness.
- Collaborated with formulation scientists to develop methods suitable for stability studies, impurity profiling, and dissolution testing.
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Analytical Method Validation:
- Conducted comprehensive validation studies according to ICH guidelines (e.g., Q2(R1), Q14), including accuracy, precision, linearity, specificity, robustness, and stability assessments.
- Utilized statistical tools to evaluate validation data and ensure compliance with regulatory requirements.
- Prepared validation reports and defended the results during regulatory inspections.
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