ISAZI

Prepare, review, and control SOPs and key documents. Review and control documents for analytical validation protocols and reports. Review instrument qualification, calibration, and maintenance data and reports. Review computer system validation documents. Ensure Good Laboratory Practice in the laboratory. Conduct training and manage training-related documents. Have sound knowledge of regulatory requirements like ICH, USFDA, EU, Schedule L-1, and effective auditing skills. Knowledge and training in NABL and other ISO standards is preferable.