_{27th February, 2025}

Summary
 
Quality Professional with experience in Quality Systems management and Validation. In addition, some knowledge or to be familiar with in PASx/MES application, MAXIMO, SAP, LIMS, QMTS and Veeva. Available during weekends and holidays as requested.
 
FUNCTIONS

• - Review and approve product MPs.
• - Approve process validation protocols and reports for manufacturing processes. - Request Quality on incident triage team.
• - Approve Environmental Characterization reports.
• - Release of sanitary utility systems.
• - Approve planned incidents.
• - Represent QA on NPI team.
• - Lead investigations.
• - Lead site audits.
• - Own site quality program procedures.
• - Designee for QA manager on local CCRB.
• - Review Risk Assessments.
• - Support Automation activities.
• - Support facilities and environmental programs.
• - Review and approve Work Orders.
• - Review and approve EMS/BMS alarms.
• - Approve NC investigations and CAPA records.
• - Approve change controls.
• - Provide lot disposition and authorize lots for shipment.

• Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.
• Experience in Quality Systems (Deviations, CAPAs, Change Controls) and Equipment, Processes and Facilities Validation.
• Knowledge or to be familiar with in PASx/MES application, MAXIMO, SAP, LIMS, QMTS and Veeva.
• Available during weekends and holidays as requested.
• Processes experience is preferred.