New Starters
Welcome Áine
Áine Galvin joined us in late January as Programme Facilitator on the Validation Programme. She has a huge wealth of knowledge and experience with her to Innopharma from her roles both as a Senior Validation Manager and as a QP. Áine is part of the team that updates and delivers the training materials on the Validation Programme & is doing an exceptional job!
Welcome once again to the team Áine.
Áine holds 20+ years’ experience spanning the pharmaceutical and biotechnology industry across formulation and aseptic fill finish (freeze dried & liquid), solid oral dose capsules and tablets, generic pharmaceutical manufacture, API Manufacture as well as inspection, primary and secondary packaging of same.
Áine’s early career encompassed QC analytical testing, method validation and technology transfer as well as regulatory submissions for New Product Introductions
(NPI). A curiosity across the multiple activities that spanned the lifecycle of a NPI while working in Melbourne Australia, prompted the completion of the MSc in Industrial Pharmaceutical Science in 2008 with RCSI/Sligo IT. This enabled Áine to perform Quality oversight of all these activities and act as Qualified Person for batch disposition to market on her return to Ireland.
A relocation from Cork (Gilead Sciences) to Dublin (Amgen Technology) in 2012 provided Áine with an in-depth knowledge of aseptic fill/finish and packaging facilities from construction through to commercial operations encompassing design, qualification, QC testing, QA oversight, validation as well as regulatory submissions and subsequent approvals to allow release to market.
Much of Áine’s career in Amgen encompassed Validation oversight and management/mentoring of a highly skilled and diverse team of validation engineers who specialised in commissioning/qualification activities, computer systems validation, sterilisation equipment validation, cleaning validation, aseptic process simulation (media fill), packaging and inspection validation as well as NPI validation activities including regulatory submissions for all new products.
Áine’s career has allowed her to work for a multitude of companies both locally and on the international stage, something for which she is very grateful for 😊