• Performed gap analysis• Revised/reformatted SOPs and audited documents of food and consumer regulations• Supported production and developing testing of compliance management systems

• Reviewed the Smoke Study Protocol and monitored the execution process• Prepared summary report of core personnel activities.• Involved, identified procedural deviations and supported the failure investigations related to Biological Quality.• Prepared qualified core personnel schedule for evaluation tracking.• Monitored and evaluated Aseptic Core Personnel Critical Activities.