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Job Description
You will be working as part of a bigger team to support the QC labs with validations, investigations, critical material qualifications and method knowledge management. Your tasks are diverse and will focus on supporting laboratories with biochemical and instrumental analytical tests. This position is limited till end of 03/2022.
Your Opportunity:
- Assure GMP compliant changes of critical materials for respective test methods
- Manage activities to support key projects (e.g. assay transfers)
- Assure GMP compliant and timely execution of QC method validations/qualifications for QC analysis method implementation and maintenance (release, IPC, stability, process qualification / process monitoring)
- Write protocols and reports for method validations, method transfers and comparability studies as well as qualification documents for critical materials, and implementation of assay controls (documentation in English)
- Work closely with QC testing labs during execution of the validation / qualification work by the QC laboratory
- Support analytical laboratory investigations (deviations, OOS, troubleshooting) and method related maintenance/administration
- Knowledge sharing of problems that were found and share solutions to drive continuous improvement
- Review of compendial requirements on a regular basis
- Support submission process
- This position is limited till end of 03/2022
Your Skills & Qualification:
- Natural sciences background (preferably (analytical) chemistry, pharmacy, technical chemistry, etc.)
- Industrial experience, i.e. GMP environment, is a plus
- Expertise with instrumental analytics and protein analysis (especially gel electrophoresis, HPLC, further e.g. nitrogen analyzers, GC, AAS/ICP)
- Knowledge and experience in analytical method verification/validation and critical reagent qualification
- Statistical knowledge and experience with data analysis
- Knowledge of regulatory requirements concerning analytical test methods (ICH/EP/USP/JP)
- Six Sigma Yellow/Greenbelt training would be beneficial but is not required
- Fluency in German and English (at least for international calls)
- Technical writing skills in English
- Target-oriented teamplayer, problem solving skills
- Analytical thinking
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work – life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer. For more insights into Takeda click here.
We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.
Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position is € 3.323,20 gross per month (full time, collective wage agreement for the chemical industry). The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.
