Alison Harrington
Validation Engineer @BioNTech SE
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WORK HISTORY
Validation Engineer @BioNTech SE
DE
Validation of Ongoing Process Validation use case of the BioNData data analytics platform, to provide realtime intuitive data analysis of LIMS data, using an Agile software development approach
EDUCATION
Royal Society of Chemistry
Bachelor of Science (BSc)
SKILLS
ABOUT ALISON HARRINGTON
Alison is a Validation and Software Quality Assurance specialist with significant deployment experience across international sites gained from delivering applications in a Pharmaceutical environment. An innovator offering proven communication, planning, influencing and financial control skills. Validation governance role for Data Integrity remediation, HPQC, Remedy, SAP, Oracle and JDE global ERP deployment projects, including management of offshore teams and remote testing tools. Led PAT, LIMS, Chromatography and data archive projects using a range of lifecycle development methodologies and contemporary quality standards, including cGMP and 21CFR part11. Conducted CSV audits and led remediation projects. Able to work effectively at all levels of the organization with a passion for optimizing business processes and managing change. Alison has a very strong understanding of technology and IT systems, gained from over 31 years experience within the pharmaceutical industry and demonstrated by a track record of delivery and influencing IT developments at a departmental, divisional and global level. Integrating validation into a variety of project lifecycle methodologies, ensuring that validation becomes part of a project delivery and not an expensive last minute add-on. Alison is on the ISPE Data Integrity SIG committee and is currently drafting material for the GAMP Data Integrity GPG. Alison has experience in the following areas: • International regulatory, validation, quality standards and practices including; GMP, GDP, GAMP and 21CFR Part 11 • Infrastructure qualification, including cloud based solutions and mobile devices • Use of AI and ML to enhance Service Delivery Management for SAP S/4 HANA implementations • Experience of formal development methodology including; Agile, Scrum, DSDM, PRINCE, RAD and Rational Enterprise tools suite. • Appreciation of Oracle database design and SQL. • Appreciation of Information Modeling techniques, including UML and XML, used to convey system build information to both business and IT staff, for COTS, bespoke and data migration projects.
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