Control issuance, revision, retrieval, and archival of QC documents — SOPs, STPs, specifications, logbooks, worksheets, MOA — per controlled document register.
Maintain document cell registers — issuance, retrieval, archival, change history.
Coordinate and ensure training of QC personnel on revised SOPs / specifications / MOA before effective dates.
Data Review & Compliance
Review and verify analytical data from instruments such as HPLC, UV-Vis spectrophotometer, pH meter, KF auto-titrator, and balances — for completeness, signatures, calculations, and ALCOA+ compliance.
Ensure testing is performed as per approved specifications and SOPs; flag any deviation in execution to supervisor.
Verify SOP implementation and compliance across QC sections through periodic walkthroughs and document checks.
Monitor GMP / GLP compliance in QC departments and follow up for corrective actions on observed gaps.
Investigation Support
Support investigation of OOS, OOT, and laboratory incidents — gather raw data, chromatograms, instrument logs, and analyst notes for investigation files.
Support continuous improvement initiatives in documentation and quality systems — paperless lab, e-logbook, LIMS adoption.