Qc Scientist

**About the role**:
You will be working as part of a bigger expert-team to support the QC labs with project related method validations. Affected methods are diverse and require a high level of method validation planning and a good general knowledge of chemical and biochemical methods.

**How you will contribute**:

- Assures GMP compliant and timely execution of method validations/qualification/verification/transfers/critical reagent qualifications
- Establish and maintain validated status of assays
- Work in project teams and represent ALC/Method in projects concerning method changes, method transfers and method implementations
- Act as SME for dedicated analytical methods and support knowledge sharing
- Support analytical assay investigations as SME for dedicated methods (OOS, CAPA, etc)
- Identify, lead and drive improvements or remediation for analytical Assays
- Knowledge sharing of problems that were found and share solutions to drive continuous improvement
- Plan and support change requests related to analytical methods
- Support creation and review of submission documents related to analytical method sections
- Act as local SME for applicable procedures
- Act as interface between other departments/sites/global teams and local QC labs related to analytical method lifecycle
- Train colleagues
- Support global harmonization and simplification

**What you bring to Takeda**:

- Technical or natural sciences background (biotechnology, biochemistry, chemistry or similar)
- Expertise with analytical methods
- Knowledge of analytical method validation and critical reagent qualification
- Statistical knowledge and experience with data analysis
- Knowledge of regulatory requirements concerning analytical test methods (EP/USP)
- 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
- Coaching/Training of others
- Knowledge of GMP regulations

**What Takeda can offer you**:
A competitive remuneration package with a minimum salary of € 3.557,47 gross per month (full-time, collective wage agreement for the chemical industry) - **the actual salary depends on your professional experience and qualifications.**
- Family-friendly company environment; Support with parental leave, dad month, Bilingual company kindergarten
- Comprehensive training programs
- In-house job rotation program
- In-house Canteen with discounts or meal vouchers
- Works council (events, festivals, shopping vouchers, etc.)
- Employee Referral Program
- Employee Recognition Program
- Takeda Resource Groups
- Medical checkups
- Free vaccination program
- Fitness Center

**More about us**:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

**Empowering our people to shine**:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

**Locations**:
AUT - Wien - Lange Allee 24

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time