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
04.2023 - 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
04.2020 - 03.2023
- 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
06.2017 - 03.2020
- 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
04.2016 - 05.2017
- 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
10.2015 - 03.2016
- 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
09.2014 - 09.2015
- QA/Compliance - Execution of supplier qualification activities
Internship
Karolinska Institutet
Stockholm
03.2013 - 08.2013
- Department of Laboratory Medicine - Division of Pathology
Resarch Assistant
Friedrich-Schiller-Universität
Jena
11.2011 - 09.2012
- 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
04.2023 - Current
QA Expert
Lonza AG
04.2020 - 03.2023
Process Expert
Novartis Pharma AG
06.2017 - 03.2020
Compliance Specialist
Novartis Pharma
04.2016 - 05.2017
QC Professional
Novartis Pharma AG
10.2015 - 03.2016
Postgraduate
Novartis Pharma AG
09.2014 - 09.2015
Internship
Karolinska Institutet
03.2013 - 08.2013
Resarch Assistant
Friedrich-Schiller-Universität
11.2011 - 09.2012
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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