Specialist Qa - Validation Process

Descripción del Empleo:
Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision. 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.
Requisitos:
Bachelor’s degree in Sciences/Engineering and 5 years of Quality experience
Experience as Quality representative within Pharmaceutical GMP Manufacturing operation environment.
Process Oversight, Batch Record Review, Events evaluation and determination of deviation.
Experience with Validation processes, execution and/or oversight.