Kristina Wikholm
Bålsta
Summary
Ambitious, responsible and driven with extensive experience (> 20 years) in Quality Assurance including supplier lifecycle management.
I am applying for the job position as Quality Engineer at Abilia because I believe I can contribute in this role with my broad experience from quality assurance perspective all the way from suppliers, manufacturing, quality control, supply, regulatory affairs.
Overview
26
26
years of professional experience
Work History
QA Supplier Lifecycle Manager
Fresenius Kabi
Kungsängen
09.2025 - Current
- Responsible for supplier qualification and requalification of APIs, excipients, raw materials and packaging materials.
- Global point of contact for suppliers of APIs and excipients regarding quality and regulatory related questions.
- Handle claims regarding suppliers of packaging materials.
- Lead and coordinate change controls ensuring cross-funtional alignment and timely implementation.
- Prepare and manage purchasing specifications and negotiate with suppliers
Design Element Responsible
Fresenius Kabi
Kungsängen
11.2021 - 09.2025
- Management of change controls related to the qualifications of suppliers and the implementation of new suppliers, raw materials in products.
- SME (Subject Matter Expert) for drug substances
- CMC documentation (Module 3) and life cycle management, including regulatory submissions (variations, NDAs and responses to health authorities)
- Close cross-functional collaboration with Sourcing, Regulatory Affairs, Quality Control and Supply Chain.
Release Officer
Fresenius Kabi
Kungsängen
09.2017 - 11.2021
- Evaluate batch batch documentation and release of APIs/Excipients/Raw materials for production.
- QA Approver of quality investigations.
- QA Approver of internal documents.
- Create and up date inspection plans i SAP.
- QA Approve weighing plans in PAS-X
Release Officer
Fresenius Kabi
Uppsala
03.2007 - 09.2017
- Evaluate batch documentation of finished products and packaging materials.
- QA Approver for quality investigations, finished products, and packaging materials.
- Support production in questions regarding quality.
Laboratory Engineer
Fresenius Kabi
Uppsala
03.2000 - 03.2007
- Wet chemical analysis, droplet size distribution techniques, HPLC, ICP-AES, ICP_MS.
- Method development ICP-AES and ICP-MS.
Education
Bachelor of Science - Chemistry, Analytical Techniques
Uppsala Univeristet
UppsalaSkills
- MS Office
- SAP
- Trackwise
- eDMS
- Platina
Languages
Svenska
First Language
Engelska
Advanced
C1
References
- References are availble upon request
Timeline
QA Supplier Lifecycle Manager
Fresenius Kabi
09.2025 - Current
Design Element Responsible
Fresenius Kabi
11.2021 - 09.2025
Release Officer
Fresenius Kabi
09.2017 - 11.2021
Release Officer
Fresenius Kabi
03.2007 - 09.2017
Laboratory Engineer
Fresenius Kabi
03.2000 - 03.2007
Bachelor of Science - Chemistry, Analytical Techniques
Uppsala Univeristet