Verified recordBiotechnology Research

Amanda Doyle

Senior Manufacturing Manager at Amgen

Based in Ireland

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Seniority

Manager

Department

Manufacturing & Production

Location

Ireland

Industry

Biotechnology Research

Company size

39K

Contact information

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Email

1 credit

a•••••••@amgen.com

Phone

5 credits

+353 ••• •••• ••••

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Background

About Amanda Doyle

KEY ACHIEVEMENTS INCLUDE - Implementation of the SP Global Quality Auditing Program - baseline audits for approx. 200 audits were completed ahead of schedule - areas of auditing expertise are Primary Packaging, Printed Packaging, API and Contract Laboratories. Project included developing all procedures, maintaining database, involved in all ongoing improvements and training of site users- Continuous effective work and assistance provided to vendors where quality issues were highlighted - feeding into the Site Quality Metrics (>40% year on year deviation reduction 2008-2010), visible reduction in Vendor Deviations initiated resulting in increased productivity on-line- Participated/Managed successful improvement projects using Six Sigma methodology: re-designed incoming inspection process (43% cycle time reduction, 50% entry reduction), restructured Retain Sample logging, storage and review process (50% entry reduction, 60% cycle time reduction)- Involved in various aspects of Technical Transfer for 33 products (liquids, tablets, pastes and powders)- specifications, supplier information, samples, and documentation etc. Specialties-Certified Lead Auditor - 6 years supplier auditing experience -17 years experience in Pharmaceutical Industry -Committed and hardworking -Strong communication skills -Proven track record in problem solving and managing change -Supervisory experience with good leadership -Vast experience in writing/reviewing reports -Excellent organisational skills and attention to detail -Flexible with ability to work on own initiative -Member of the Quality Unit in an IMB/FDA/cGMP regulated environment

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