Specialist Qa

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. Support Automation activities.
Requisitos:
Bachelor’s degree in Life Sciences - Biology, Chemistry, Engineering, Physics, Environmental Sciences and 5 years of directly related experience
Experience in Quality Systems, reviewing and approving deviation records, work orders, sanitization forms, documentation logbooks, and manufacturing processes and batch record.
Knowledge in critical utilities and biopharmaceutical facilities support.
Knowledge of electronic batch record, preferably (MES WERUM).
Non-Standard shift (COVID-19 - 12hrs shifts, 8hrs shift/3 shifts)