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Job description

Job Description: • Review analytical data, chromatograms, calculations, and laboratory records. • Verify compliance of laboratory activities with GLP, GMP, and data integrity guidelines. • Review analytical method validation, method transfer, cleaning validation, and stability study reports. • Monitor control of laboratory instruments, calibration, qualification, and maintenance records. • Review OOS/OOT investigations and ensure timely closure. • Ensure adherence to ALCOA+ principles and regulatory expectations regarding data integrity.

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