Manuel Mainer Email & Phone Number

After my degree in nutritional sciences in 2005 I started in 2006 at Baxter as Quality Lab associate in Orth/Donau.In 2009 for one of the QC departments in Orth a validation team was established which I was a part of from the very beginning. Responsibilities were analytical instrument qualification (AIQ), analytical method validation, creating and revising SOPs, change control, CAPA management & control charting for analytical methods.Something about 2011 our team got the responsibility for the whole QC area (meaning three QC departments) in Orth where analytical method validation was split off and went back to the QC labs. So our focus was AIQ and computerized system validation and all that quality management systems regarding equipment.As we went through several reorganisations and restructurings for a couple of years starting in 2013 (transfer of commercial vaccines in Orth to Pifzer, Baxalta spin off from Baxter and then Baxalta becoming a part of Shire, ) the decision was made to dissolve our AIQ team with the end of 2017. Now I'm taking the opportunity to go back to university of vienna to start a teacher training programme for the subjects chemistry, biology & probably mathematics in which I'm already quite involved.

Listed skills include Validation, Capa, Change Control, Gmp, and 12 others.