Lena Fürstenau
Auetal
Summary
In my previous work, I have dealt intensively with cleanroom qualifications, microbiological tests, risk analyses and GMP guidelines. My expertise includes the qualification of cleanrooms, hygiene concepts, environmental monitoring and the creation and review of quality-relevant documents. I also work closely with interdisciplinary teams to ensure that all regulatory requirements are met.
My way of working is characterized by diligence, analytical thinking and a structured approach. I also have strong communication skills that enable me to work efficiently with both internal departments and external partners.
Overview
6
6
years of professional experience
Work History
Specialist Sterility Assurance
Octapharma Produktionsgesellschaft mbH
11.2020 - Current
- Creation of SOP, Qualification protocols/reports
- Qualification of cleanrooms
- Creation and planning of monitoring protocols
- Determination of hygiene measures
- Aseptic process simulation support
- Implementation of employee qualification and training
- Organization and guidance of employees
- Creation of batchwise monitoring reports
- Collaboration in CAPA measures and deviation processing
- Audit experience
Parental Leave
Octapharma Produktionsgesellschaft mbH
10.2022 - 10.2023
Instructor
Octapharma Produktionsgesellschaft mbH
05.2020 - 03.2021
- Part-time
Specialist Purification
Octapharma Produktionsgesellschaft mbH
06.2019 - 10.2020
- Organization and guidance of employees
- Monitoring the manufacturing process, production of bulk ware
- Product control and release
- Procurement and control of raw material and auxiliaries
- Bookings of incoming and outgoing goods
- Documentation
Education
Instructor according to AEVO -
IHK Hannover
Hannover, Niedersachsen09.2021
Dual apprenticeship - pharmaceutical technician
Justus-von-Liebig-Schule
Hannover, Niedersachsen06.2019
Study - chemistry
Leibniz Universität Hannover
Hannover, NiedersachsenAbitur -
Gymnasium Melle
Melle, Niedersachsen07.2016
Skills
- CGMP
- FDA Knowledge
- DIN EN ISO 14644-1
- IT Knowledge
- PLS
- MS Office
- MODA
- Trackwise
- ECDOC
- Time management
- Organizational skills
- Team building
- Audit reporting
- Teamwork
Languages
Latin
English
Further Education
- 04/01/22, Concept Heidelberg: Hygiene officer block II
- 03/01/24, Concept Heidelberg: Quality Oversight
Timeline
Parental Leave
Octapharma Produktionsgesellschaft mbH
10.2022 - 10.2023
Specialist Sterility Assurance
Octapharma Produktionsgesellschaft mbH
11.2020 - Current
Instructor
Octapharma Produktionsgesellschaft mbH
05.2020 - 03.2021
Specialist Purification
Octapharma Produktionsgesellschaft mbH
06.2019 - 10.2020
Dual apprenticeship - pharmaceutical technician
Justus-von-Liebig-Schule
Abitur -
Gymnasium Melle
Instructor according to AEVO -
IHK Hannover
Study - chemistry
Leibniz Universität Hannover
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