Prepare and review technical documentation including protocols, Standard Operating Procedures (SOPs), validation reports, specifications, and investigation reports.
Review analytical data to ensure accuracy, integrity, and compliance with current Good Manufacturing Practice (cGMP) requirements.
Lead laboratory investigations, deviations, Out-of-Specification (OOS) results, and root cause analysis, driving timely and effective corrective and preventive actions (CAPA).
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Prepare and review technical documentation including protocols, Standard Operating Procedures (SOPs), validation reports, specifications, and investigation reports.
Review analytical data to ensure accuracy, integrity, and compliance with current Good Manufacturing Practice (cGMP) requirements.
Lead laboratory investigations, deviations, Out-of-Specification (OOS) results, and root cause analysis, driving timely and effective corrective and preventive actions (CAPA).
...