Lead or participate in investigation arising from laboratory investigation, incidents recommendations remedial actions for follow-up
Draft, review and update appropriate laboratory documents such as testing protocol, procedures, analytical methods and guidelines relating to GMP and operational framework of the laboratory
Updated with pharmacopeial and other health agencies guidelines
...
Coordinate incoming quality inspection and first article inspection activities performed by Laboratory Technicians to ensure purchased materials meet specification. Support containment, disposition, and timely follow-up of non-conforming materials with suppliers and internal stakeholders.
Lead cross-functional investigations of quality issues using structured problem-solving methodologies (A3, 4-Step Management, Root Cause Analysis, FMEA, SPC, etc.).
Manage the plant calibration system to ensure measuring and testing equipment remain calibrated, traceable and fit for intended use.
...