Typically 2 to 6+ years in pharmaceutical QC, with specific hands-on expertise in HPLC analysis.
Role & responsibilities
- Data Review & Validation: Verify HPLC chromatograms, sequence tables, integration parameters, and raw data against approved test methods and specifications.
- Compliance & Data Integrity: Ensure all testing complies with global regulatory guidelines (e.g., USFDA, MHRA) and ALCOA+ principles.
- System Suitability (SST): Check that system suitability criteria (e.g., tailing factor, theoretical plates, %RSD) are met prior to sample analysis.
- Out of Specification (OOS): Identify and escalate any Out of Specification (OOS) or Out of Trend (OOT) results, assisting in deviation investigations and root cause analysis.
- Documentation: Review Certificates of Analysis (CoA), analytical reports, and instrument logbooks for completeness and accuracy.