Eva D. Email and Phone Number

Led and participated in continuous improvement projects following Kaizen principles in support of management initiatives:-Defined project scope and objectives with management-Prepared associated protocols, reports and status updates-Developed work plans, key metrics, schedules and resource requirements with team members-Provided training to support projects-Analyzed data and provided recommendations on improving procedures and processesParticipated in the development… Show more Led and participated in continuous improvement projects following Kaizen principles in support of management initiatives:-Defined project scope and objectives with management-Prepared associated protocols, reports and status updates-Developed work plans, key metrics, schedules and resource requirements with team members-Provided training to support projects-Analyzed data and provided recommendations on improving procedures and processesParticipated in the development of strategies, to ensure that all operations efficiently produced quality product that met costing, scheduling, compliance and safety goalsPartnered with production operators to evaluate and enhance production processes and practices Prepared, revised and managed the review process for master production formulation and SOPs Mentored production summer students to develop skills for future success Show less

Reviewed batch records, assessed impact of incidents and processing deviations, and released product for saleServed as primary contact for production and quality auditors, to assist in trouble shooting and problem solving for quality related issuesParticipated in inter-departmental meetings and teams, to provide guidance and ensure quality processes were followedTrained production personnel in support of GMPsInvestigated product complaints, events, issues and… Show more Reviewed batch records, assessed impact of incidents and processing deviations, and released product for saleServed as primary contact for production and quality auditors, to assist in trouble shooting and problem solving for quality related issuesParticipated in inter-departmental meetings and teams, to provide guidance and ensure quality processes were followedTrained production personnel in support of GMPsInvestigated product complaints, events, issues and systems through which process improvement could be identified, recommended, implemented and consistently managedConducted internal audits and authored/revised SOPsApproved and supervised off line rework and inspection activitySupported regulatory affairs and validation activities through preparation and review of data and documentation Show less

Prepared, reviewed and coordinated approval process for master manufacturing and packaging batch recordsGenerated new SOPs and revised existing SOPs Designed, implemented and provided training for document change control, change control and deviation report follow-up system Assessed and delegated follow-up actions to Document Change ControlsVerified and approved of Bills of MaterialsCoordinated Internal Auditing Program