Sr. Qa Specialist-Quality Management System-Rci

Descripción del Empleo:
In support of the Company’s Quality Assurance program acts as the technical specialist. Review and approve product MP’s. Approve process validation protocols and reports for mfg. Processes. Represent Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Own site quality program procedures. Designee for QA manager on local CCRB.
Requisitos:
Minimum 8 years of experience working directly with Quality in the regulated industry. Experience being in a Person-in-Plant role. Experience using Quality Management systems (deviation, change control, CAPAs, EVs, supplier investigations) and SAP. Knowledge in: Biopharm manufacturing process, Drug commercialization process, GXPs and understands a regulated environment. Objective and the ability to manage root cause investigations and corrective actions in a timely manner, good communication skills (live discussions, emails, presentations, etc), good story telling skills to appropriately document investigations and follow up in Quality Management Systems. Bachelor degree in Sciences or Engineering Completed. Must be available to work Administrative, 2nd shift and Weekends. Qualified candidates please send resume to: **********