Manuel Mainer
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Manuel Mainer Email & Phone Number

Ex Validation Specialist at Shire. Now: teacher training program at University of Vienna at Shire
Location: Austria, Austria, Austria 4 work roles 2 schools
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Role
Ex Validation Specialist at Shire. Now: teacher training program at University of Vienna
Location
Austria, Austria, Austria
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Who is Manuel Mainer? Overview

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Manuel Mainer is listed as Ex Validation Specialist at Shire. Now: teacher training program at University of Vienna at Shire, a company with 8909 employees, based in Austria, Austria, Austria. AeroLeads shows a matched LinkedIn profile for Manuel Mainer.

Manuel Mainer previously worked as Validation Specialist at Shire and Validation Specialist at Baxalta. Manuel Mainer holds Master'S Degree, Naturwissenschaften from Universität Wien.

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Shire

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Profile bio

About Manuel Mainer

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.

Current workplace

Manuel Mainer's current company

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Shire
Shire
Ex Validation Specialist at Shire. Now: teacher training program at University of Vienna
dublin, dublin, ireland
Website
Employees
8909
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4 roles

Manuel Mainer work experience

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Validation Specialist

Current

Orth/Donau

Quality Lab Support & Quality Management SystemsAnalytical Equipment Validation/Qualification (incl. Computerized Systems Validation) & Equipment Lifecycle ManagementControl Charts (Northwest Analytics / SQL*LIMS)Creating and Revision of Standard Operating Procedures (SOPs)Change ControlEquipment Purchasing

Jun 2016 - Present

Validation Specialist

Orth/Donau

Quality Lab Support & Quality Management SystemsAnalytical Equipment Validation/Qualification (incl. Computerized Systems Validation)Control Charts (Northwest Analytics / SQL*LIMS)Creating and Revision of Standard Operating Procedures (SOPs)Change Control

Jul 2015 - Jun 2016

Validation Specialist

Orth/Donau

AnalysenmethodenvalidierungEquipmentvalidierung (Spezifikationen URS/FDS, Risikoanalyse, IQOQPQ)Erstellung von SOPs (Standardarbeitsanweisungen)Change ControlAbweichungsmanagement (Trackwise)Erstellen von Methoden in LIMSProgrammieren von Controlcharts in NWA

Mar 2009 - Jun 2015

Quality Control Laboratory Technician

Orth/Donau

ELISA,Flowzytometrie,Hämagglutinationsinhibitions (HAI)-TestsQC Labor Dokumentation

Jun 2006 - Feb 2009
Team & coworkers

Colleagues at Shire

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2 education records

Manuel Mainer education

Lehramt Unterrichtsfach Chemie, Biologie & Umweltkunde Und Mathematik

FAQ

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What company does Manuel Mainer work for?

Manuel Mainer works for Shire.

What is Manuel Mainer's role at Shire?

Manuel Mainer is listed as Ex Validation Specialist at Shire. Now: teacher training program at University of Vienna at Shire.

Where is Manuel Mainer based?

Manuel Mainer is based in Austria, Austria, Austria while working with Shire.

What companies has Manuel Mainer worked for?

Manuel Mainer has worked for Shire, Baxalta, and Baxter International Inc..

Who are Manuel Mainer's colleagues at Shire?

Manuel Mainer's colleagues at Shire include Ricardo Bartolomé Castilla, Bruce Massarotti, Jack Merkel, Bob Dempsey, and Larry Maciel.

How can I contact Manuel Mainer?

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What schools did Manuel Mainer attend?

Manuel Mainer holds Master'S Degree, Naturwissenschaften from Universität Wien.

What skills is Manuel Mainer known for?

Manuel Mainer is listed with skills including Validation, Capa, Change Control, Gmp, 21 Cfr Part 11, V&V, Fda, and Sop.

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