Scheduler - Dubai, United Arab Emirates - Somerset NHS Foundation Trust

Description

:

Perform one or more ofthe following duties and responsibilities in support of siteQuality Assurance program under minimal supervision. Review andapprove product MPs. Approve process validation protocols andreports for manufacturing processes. Request Quality on incidenttriage 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 onlocal CCRB. Review Risk Assessments. Support Automation activities.
Support facilities and environmental programs. Review and approveWork Orders. Review and approve EMS/BMS alarms. Approve NCinvestigations and CAPA records. Approve change controls. Providelot disposition and authorize lots for shipment.


EDUCATION:

Doctorate degree or Masters degree and 3 yearsof directly related experience or Bachelors degree and 5 years ofdirectly related experience or Associates degree and 10 years ofdirectly related experience.

FUNCTIONSResponsible for providing Quality oversight to ensure thatoperations for licensed pharmaceutical products are manufactured,tested, and stored, according to current Good ManufacturingPractices (cGMP) and other applicable regulations.

Ensures thatfacilities, equipment, materials, organization, processes,procedures and products comply with cGMP practices and otherapplicable regulations. Review and approval of Electronic BatchRecords and related documentation to support Drug SubstanceDisposition Process. Performs SAP systems transactions to supportbatch processing and disposition requirements. Data entry, reviewand approval of LIMS sample test results to support batchprocessing and disposition requirements. Performs review, approvaland tracking of cGMP processes, procedures, assays, documents andrecords, including but not limited to Nonconformance s, CAPAs, andvalidations Supports Continual Improvement initiatives, programsand projects Ensures that deviations from established proceduresare investigated and documented per procedures Collaborates crossfunctionally as needed to ensure the Quality Management Systemprocesses are executed in accordance with established proceduresAlerts senior management of quality, compliance, supply and safetyrisks Represents the quality unit during audits and inspections asneeded Completes required assigned training to permit execution ofrequired tasks Performs additional duties as specified bymanagement

PREFERRED QUALIFICATION Projectmanagement skills Strong organizational skills, including abilityto follow assignments through to completion Initiate and lead crossfunctional teams Enhanced skills in leading, influencing andnegotiating Strong knowledge in area of expertise Collaborate andcoordinate with higher level outside resources Strong knowledge ofand experience with processes involved in manufacturing, QA, QC,validation and process development Demonstrate ability to interactwith regulatory agencies

COMPETENCIES/SKILLSProject management skills, Strong organizational skills, includingability to follow assignments through to completion, Initiate andlead cross functional teams, Enhanced skills in leading,influencing and negotiating, Strong knowledge in area of expertise,Collaborate and coordinate with higher level outside resources,Strong knowledge of and experience with processes involved inmanufacturing and distribution, QA, QAL, validation and processdevelopment, Demonstrate ability to interact with regulatoryagencies, Strong word processing, presentation, database andspreadsheet application skills, Strong communication (both writtenand oral), facilitation and presentation skills, Strong skill inworking independently and to effectively interact with variouslevels, Advanced data trending and evaluation.

Ability to evaluatecompliance issues, Demonstrate site Values/LeadershipPractices.