Qc Method Validation Specialist

vor 1 Tag

Wien, Österreich Takeda Pharmaceutical Vollzeit

**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**:

- Assure GMP compliant and timely execution of QC method validations / qualifications for QC analysis method (release, stability) implementation and maintenance
- Write protocols and reports for method validations and maintain method lifecycle (assay control adjustments, etc.)
- Coordinate method implementation at external contract test laboratory
- Manage activities to support project milestones
- Support and collaborate with the project management team and other internal departments
- Work closely with QC testing labs during execution of the validation / qualification work by the QC laboratory
- Support analytical laboratory investigations during method validation
- This is a temporary position for 12 months

**What you bring to Takeda**:

- Natural sciences background (analytical chemistry, pharmacy, technical chemistry, molecular biology, etc.)
- Hands-on experience with analytical method validations, especially within GMP environment
- Expertise with bio-analytics and excipient analysis: clotting and chromogenic assays, total protein analysis, HPLC, ICP-OES, bioburden
- Statistical knowledge and expertise in data analysis
- Knowledge of regulatory requirements concerning analytical test methods (ICH/EP/USP/JP)
- Good IT-skills (MS Office, MS Teams, Minitab)
- **
Fluency in German **and** English is mandatory**
- Technical writing skills in English
- Analytical thinking and continuous improvement mindset
- Target-oriented team-player with high level of independency

**What Takeda can offer you**:
A competitive remuneration package with a minimum salary of € 3.389,68 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
- In-house cleaning service

**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 diverseworkforce 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**:
Fixed Term (Fixed Term)
**Time Type**:
Full time

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