Andrea Studer

Andrea Studer Email and Phone Number

QA Manager IMP Drug Product Parenterals @ Roche
Zofingen, AG, CH
Andrea Studer's Location
Zofingen, Aargau, Switzerland, Switzerland
About Andrea Studer

Andrea Studer is a QA Manager IMP Drug Product Parenterals at Roche. They is proficient in Spanisch, Französisch and Englisch.

Andrea Studer's Current Company Details
Roche

Roche

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QA Manager IMP Drug Product Parenterals
Zofingen, AG, CH
Website:
roche.com
Employees:
101170
Andrea Studer Work Experience Details
  • Roche
    Qa Manager Imp Drug Product Parenterals
    Roche
    Zofingen, Ag, Ch
    View
  • Roche
    Qa Manager Imp Drug Product Parenterals - Contract Basis
    Roche May 2024 - Present
    Basel, Schweiz
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  • Csl Behring
    Manager Regulatory Compliance
    Csl Behring Nov 2016 - Jun 2023
    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
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  • Csl
    Manager, Head Of Regulatory Compliance
    Csl Nov 2016 - Apr 2022
    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
    View
  • Arena Pharmaceuticals
    Manager Auditing & Contracts
    Arena Pharmaceuticals Jun 2013 - Sep 2016
    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
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  • Siegfried - Expect More
    Group Head Of Batch Record Review Group
    Siegfried - Expect More Apr 2011 - May 2013
    Zofingen
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  • Siegfried - Expect More
    Manager Quality Assurance
    Siegfried - Expect More Jan 2005 - May 2013
    Zofingen
    Deputy Head Quality Assurance, API Batch Release, Change Control, Deviation Handling, Process Validation, PQR
    View
  • Siegfried - Expect More
    Manager Process Validation And Equipment Qualification
    Siegfried - Expect More Oct 2000 - Dec 2004
    Zofingen
    Process Validation, Equipment Qualification, Cleaning Validation
    View

Andrea Studer Education Details

Frequently Asked Questions about Andrea Studer

What company does Andrea Studer work for?

Andrea Studer works for Roche

What is Andrea Studer's role at the current company?

Andrea Studer's current role is QA Manager IMP Drug Product Parenterals.

What schools did Andrea Studer attend?

Andrea Studer attended Universität Basel.

Who are Andrea Studer's colleagues?

Andrea Studer's colleagues are Nicolás Cuevas González, Juan Cruz, Ahmed Tantawy, Melissa Egles (Haußmann), Andreas Stadler, Walter Villar, Archit Kumar.

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