Andrea Studer
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Andrea Studer Email & Phone Number

QS and QA Manager IMP Quality at Roche
Location: Zofingen, Aargau, Switzerland 9 work roles 1 school
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Current company
Role
QS and QA Manager IMP Quality
Location
Zofingen, Aargau, Switzerland
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Who is Andrea Studer? Overview

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Andrea Studer is listed as QS and QA Manager IMP Quality at Roche, a with 101170 employees, based in Zofingen, Aargau, Switzerland. AeroLeads shows a matched LinkedIn profile for Andrea Studer.

Andrea Studer previously worked as QA Manager IMP Drug Product Parenterals at Roche and QA Manager IMP Drug Product Parenterals - contract basis at Roche. Andrea Studer holds Diplom, Chemistry from Universität Basel.

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Roche

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About Andrea Studer

Andrea Studer is a QS and QA Manager IMP Quality at Roche. They is proficient in Spanisch, Französisch and Englisch.

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Roche
Roche
QS and QA Manager IMP Quality
Zofingen, AG, CH
Website
Employees
101170
AeroLeads page
9 roles

Andrea Studer work experience

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Qs And Qa Manager Imp Quality

Zofingen, Ag, Ch

Qa Manager Imp Drug Product Parenterals

Zofingen, Ag, Ch

Qa Manager Imp Drug Product Parenterals - Contract Basis

Basel, Schweiz

Manager Regulatory Compliance

Bern, Bern, Schweiz

Main tasks:Ensuring an effective and efficient management of all types of Audits and Inspections (national and international) including planning, preparation, hosting, and follow-upPrimary contact of Swissmedic for Inspection relevant topics and supporting communication of reportable changes to Swissmedic according to MPLO, Art. 41Maintaining Swiss Manufacturing License and related GMP certificatesPlanning, preparation, performance, and follow-up of Self Inspections and Training of Self Inspection AuditorsIdentification of new and changed regulations and inspection trends and evaluation of their relevance for the companySite representative in global Communities of Standardization/Practices

Nov 2016 - Jun 2023

Manager, Head Of Regulatory Compliance

Csl

Bern, Schweiz

Additional tasks:Technical and personal management of the Regulatory Compliance Team Responsible for the issuance, review and negotiation of quality agreements with other CSL sites, Customers and Service Providers

Nov 2016 - Apr 2022

Manager Auditing & Contracts

Zofingen, Kanton Aargau, Schweiz

Management of all supplier qualification activitiesAudits of suppliers, service providers and contract laboratories Preparation, hosting and follow-up of customer audits and health authority inspections including CAPA-plan preparationPerformance of internal auditsNegotiation of Quality Agreements with customers, subcontractors and service providers

Jun 2013 - Sep 2016

Manager Quality Assurance

Zofingen

Deputy Head Quality Assurance, API Batch Release, Change Control, Deviation Handling, Process Validation, PQR

Jan 2005 - May 2013

Manager Process Validation And Equipment Qualification

Zofingen

Process Validation, Equipment Qualification, Cleaning Validation

Oct 2000 - Dec 2004
Team & coworkers

Colleagues at Roche

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1 education record

Andrea Studer education

FAQ

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What company does Andrea Studer work for?

Andrea Studer works for Roche.

What is Andrea Studer's role at Roche?

Andrea Studer is listed as QS and QA Manager IMP Quality at Roche.

Where is Andrea Studer based?

Andrea Studer is based in Zofingen, Aargau, Switzerland while working with Roche.

What companies has Andrea Studer worked for?

Andrea Studer has worked for Roche, Csl Behring, Csl, Arena Pharmaceuticals, and Siegfried - Expect More.

Who are Andrea Studer's colleagues at Roche?

Andrea Studer's colleagues at Roche include Patrice Buess, Kenza Tazairt, Pietro Dal Bianco, Alena Zelinkova, and Rafaela Souza.

How can I contact Andrea Studer?

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What schools did Andrea Studer attend?

Andrea Studer holds Diplom, Chemistry from Universität Basel.

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