Independently review analytical method development data, protocols, reports, and supporting documentation to ensure accuracy, completeness, and scientific soundness.
Evaluate chromatographic method development strategies, experimental design, and data interpretation for alignment with client expectations and regulatory requirements.
Verify analytical data, including chromatographic outputs (e.g., HPLC, GC, IC, GCMS, LCMS), calculations, system suitability, and method performance characteristics.
Ensure all work complies with GMP, data integrity principles (ALCOA+), internal SOPs, and applicable regulatory guidelines (e.g. ICH).
Identify discrepancies, errors, or gaps in data and documentation, and drive resolution with appropriate stakeholders.
Partner with Analytical Scientists and Project Group Leaders to ensure accurate interpretation and reporting of method development ...