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Summary

name: eimear ryan position:- Pharmaceutical Quality Systems Analyst. (based dublin, ireland) qualifications:- Applied science (dit), graduate diploma in it (dcu) additional:- lean Six Sigma green belt (hetac qqi level 7 certificate in Process Engineering) skills:- lean Six Sigma, SAP, trackwise, apr reports, technical agreements, self inspections.

Experiences

Current Experience

  • Quality Assurance (QA) Manager


    Since January 2015

    • lean Six Sigma green belt qualified (qqi / hetac) certificate in Process Engineering project - reduction in the number of deviations caused by personnel error with proven sustainable results.

    SAP – maintenance of qm master data on SAP. projects – part of a SAP project team to enhance and develop SAP on site involving input into user requirement and functional specifications stages, uat test script development, writing and execution. sme quality master data for the project to migrate to allergan SAP system

    • experienced in trackwise ™ web based application database which is an enterprise Quality Management solution that manages the following quality processes in a centralized database: Change Control, deviation management and corrective action / preventive action, limit, complaints and fame.

    • excellent Technical Writing ability applied to writing of annual product quality reviews and preparation and revision of quality/technical agreements which establish current Good Manufacturing Practice (cGMP) responsibilities between contract partners according to both FDA and eu guidelines.

    • part of an Internal Audit team which carry out and report on self inspections ensuring Compliance with cGMP’s and standard operating procedures.

    • proficient in Database design and development through microsoft™ Excel and access Applications. • experience with edocs (author and approver), ms™ project, ms™ visio and minitab.

    • Lean Six Sigma Green Belt Qualified (QQI / HETAC) Certificate in Process Engineering Project - Reduction in the number of deviations caused by personnel error with proven sustainable results.

    • SAP – Maintenance of QM master data on SAP. Projects – part of a SAP project team to enhance and develop SAP on site involving input into user requirement and functional specifications stages, UAT test script development, writing and execution. SME Quality master data for the project to migrate to Allergan SAP system

    • Experienced in Trackwise ™ web based application database which is an enterprise quality management solution that manages the following quality processes in a centralized database: Change control, Deviation management and Corrective Action / Preventive action, LIMIT, Complaints and FAME.

    • Excellent Technical writing ability applied to writing of Annual Product Quality Reviews and preparation and revision of Quality/Technical Agreements which establish current Good Manufacturing Practice (cGMP) responsibilities between contract partners according to both FDA and EU guidelines.

    • Part of an internal audit team which carry out and report on self inspections ensuring compliance with cGMP’s and standard operating procedures.

    • Proficient in database design and development through Microsoft™ Excel and Access applications. • Experience with EDocs (author and approver), MS™ Project, MS™ Visio and Minitab.

  • Quality systems technician


    Since January 2002

Past Experience

Knowledge

LinkedIn Assessment :
TrackwiseQuality AgreementsGreen BeltLean Six SigmaQuality AssuranceFDAGMPChange ControlSOP21 CFR Part 11GXPISOValidationPharmaceutical IndustryLIMSCAPATrain the Trainer CertificationQuality SystemSAP ERP

Education

  • Graduate Diploma in Information Technology in IT from Dublin City University in 2001
  • Wholetime applied Science degree in Chemistry, physics, Food science & technology from DIT Kevin street in 1996

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
French
Professional Proficiency
German
Elementary Proficiency

Area / Region

Dublin, Ireland

Others

Driving License
  • Yes

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