- Assure GMP compliant and timely execution of QC method validations/qualifications for QC analysis method (release, IPC, stability, process qualification / process monitoring) implementation and maintenance
- Manage activities to support key projects (e.g. assay transfers)
- Plan ICH conform method validations / qualifications
- Write protocols and reports for method validations / qualifications, method transfer and comparability studies as well as qualification documents for standards and reagents, and implementation of assay controls
- Work closely with QC testing labs during execution of the validation / qualification work by the QC laboratory
- Lead and drive analytical assay investigations (OOS, CAPA, etc)
- Knowledge sharing of problems that were found and share solutions to drive continuous improvement
- Create and review submission documents
- Plan and document change requests related to analysis methods
- Technical or natural sciences background (biotechnology, biochemistry, chemistry or similar)
- Expertise with analytical methods (photometric tests, enzymatic/biochemical tests, residual moisture tests, wet-chemistry tests, technical tests for packaging and other raw material, compendial raw material tests)
- Knowledge of analytical method validation and critical reagent qualification
- Experience in problem solving (facilitation and application of tools)
- Statistical knowledge and experience with data analysis
- Knowledge of regulatory requirements concerning analytical test methods (EP/USP)
- Six Sigma Greenbelt training would be beneficial but is not required
- Fluency in German and English (sufficient for international teleconference calls)
- Technical writing skills in English and German
- Target-oriented teamplayer, problem solving skills
- Analytical thinking
As a leading global biotechnology company we have one mission every day: to lastingly improve the lives of people living with rare diseases. Crucial to our mission are our employees - our biggest asset - who enjoy a range of benefits and career opportunities, such as trainee and training programs, job rotations, apprenticeships, work-life balance (certified family friendly), company kindergarten, wellness center, cafeteria, etc. Here you can learn more about Shire in Austria.
We offer outstanding opportunities to motivated people regardless of your gender, age, skin color, ethnicity, sexual orientation or physical handicaps. Diversity is part of our success!
The minimum salary for this position is € 3.065,25 gross per month (full-time); increased payment is possible. We are looking forward to your application.