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Senior Product Stability Specialist
vor 1 Monat
**About the role**:
As a Senior Product Stability Specialist, you will be in charge of various projects linked to Stability Studies for Drug Products, Drug Substances and Intermediates.
**How you will contribute**:
- Project Management of Stability Studies for Drug Products, Drug Substances and Intermediates as well as associated Data Evaluations and Documentation
- Assignment and continuous Monitoring of product shelf life
- Authoring of technical documents for regulatory submissions
- SME guidance for regular SMEs
- Management of stability studies for assigned products
- Generation of stability protocols and stability reports (e.g. final reports, PQRs, annual reports)
- Authoring and review of stability sections for regulatory submissions
**What you bring to Takeda**:
- High school degree and several years of work experience preferably in pharmaceutical or associated industry
- Bachelor/ Master Degree in Science or Engineering or several years of Experience in pharmaceutical Industry Science related degree is preferred
- Knowledge and understanding of ICH and other regulatory requirements.
- Knowledge and ability to author technical documents
- Experience with various quality systems (e.g. investigations, CAPAs and change controls)
- Fluent in English (written and oral)
- Self-independent work attitude
**What Takeda can offer you**:
A competitive remuneration package with a minimum salary of € 3.909,67 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 - Industriestrasse 72
**Worker Type**:
Employee
**Worker Sub-Type**:
Fixed Term (Fixed Term)
**Time Type**:
Full time