Maxi Heer
Oberbuchsiten
Summary
In the world of aseptic manufacturing I'm feeling at home - with my mind, skillset and experiences in the past 10 years within the pharmaceutical industry, I want to support your team finding the best solutions by being goal oriented, supportive and having in mind the best outcome for our patients and the company.
Overview
13
13
years of professional experience
1
1
Certification
Work History
QA Manager
Lonza AG
2023.04 - Current
- Sterility Assurance Manager - Oversight of aseptic processing and contamination control strategy across the DPS network
- Supervision and execution of GMP compliance activities like changes, document management, on-site support for investigations related to non-conformities for manufacturing
QA Expert
Lonza AG
2020.04 - 2023.03
- Team Lead QA Oversight - Implementation and execution of QA Oversight for the production of sterile dosage forms of pharmaceutical products (QA on the shop floor)
Process Expert
Novartis Pharma AG
2017.06 - 2020.03
- Aseptic Filling and Compounding expert - Definition of manufacturing processes for compounding, filling and visual inspection of sterile drug products (including deviation investigation and implementation of changes/optimizations)
Compliance Specialist
Novartis Pharma
2016.04 - 2017.05
- Supplier Qualification specialist - "Quality & Follow-Up Responsible Person" for external audits, creation of quality agreements and material specifications with external companies, change management
QC Professional
Novartis Pharma AG
2015.10 - 2016.03
- QA Analytics - Execution of release analysis for solid dosage forms of pharmaceutical products (including physical and chemical analysis methods like HPLC, TLC, dissolution)
Postgraduate
Novartis Pharma AG
2014.09 - 2015.09
- QA/Compliance - Execution of supplier qualification activities
Internship
Karolinska Institutet
Stockholm
2013.03 - 2013.08
- Department of Laboratory Medicine - Division of Pathology
Resarch Assistant
Friedrich-Schiller-Universität
Jena
2011.11 - 2012.09
- Chair of Pharmaceutical Technology
Education
Master of Science - Pharmaceutical Biotechnology
University of Applied Sciences Jena
Bachelor of Engineering - Biotechnology
University of Applied Sciences Jena
Skills
- Contamination Control Strategy
- Risk analysis and management
- Aseptic training
- Manufacturing of sterile dosage forms
- Clean room concept
- Cleaning and Disinfection concept
Languages
German
First Language
English
Proficient (C2)
C2
Italian
Beginner
A1
Certification
- Management Development Program Lonza AG - 2022
- Activate Program Lonza AG - 2021
- Data Integrity Advanced Course - 2017
Timeline
QA Manager
Lonza AG
2023.04 - Current
QA Expert
Lonza AG
2020.04 - 2023.03
Process Expert
Novartis Pharma AG
2017.06 - 2020.03
Compliance Specialist
Novartis Pharma
2016.04 - 2017.05
QC Professional
Novartis Pharma AG
2015.10 - 2016.03
Postgraduate
Novartis Pharma AG
2014.09 - 2015.09
Internship
Karolinska Institutet
2013.03 - 2013.08
Resarch Assistant
Friedrich-Schiller-Universität
2011.11 - 2012.09
Master of Science - Pharmaceutical Biotechnology
University of Applied Sciences Jena
Bachelor of Engineering - Biotechnology
University of Applied Sciences Jena
- Management Development Program Lonza AG - 2022
- Activate Program Lonza AG - 2021
- Data Integrity Advanced Course - 2017
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