DescripciónDescription- 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.
Requisitos RequirementsEducation: Doctorate degree or Master's degree and 3 years of directly related experience.
Bachelor's degree and 5 years of directly related experience years of directly related experience.
Sciences or Engineering
Preferred Qualifications:
Expertise in Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control).
Hands on experience in electronic systems for instance: Documentation platforms (CDOCS), Maximo, Trackwise, LIMS, electronic batch record (MES) and SAP.
Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements.
Validated experience as Quality Contact for sophisticated projects involving new drug substance/products with experience in commissioning, facility, utility, and equipment qualifications.
Enhanced s
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