Quality Specialist LOC (f/m/d), Hybrid
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As the Quality Specialist, you will support LOC Quality in all aspects of Quality Assurance in accordance to Austrian regulations and Takeda. You will report to the Manager, Quality Assurance
Be the LOC administration of electronic document management and training systems in an administrator role, setup and assignment of trainings in Takeda systems and tools
Maintain the LOC QMS including coordination of Gap Assessments of global processes
Create and maintain local SOPs and other quality relevant documents
Change Control & CAPA management and monitoring
Manage and support local deviations, support escalations and field corrective actions
Participation in internal and external audit.
Participation in preparation of monthly reporting of LOC Quality Council and Metrics report
Support health authority communications on product quality issues affecting the country
Participate in LOC, GQ projects as assigned by Line Manager
Promote, encourage and demonstrate commitment to Takeda-ism philosophy and values.
Act according to Compliance, Ethical codes and Legal standards.
Medium or Advanced degree in scientific discipline or applicable health sciences field (biotech, pharma, chemistry, or biology field)
Experience and track record in pharmaceutical companies in last 3 years, with exposure to audits
Meet requirements for being Responsible Person according to Austrian legislation, Arzneimittelbetriebsordnung § 10 Section 3
Fluency in spoken and written German and English
Communication skills and organization skills.
Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, work together as a team leader or team member, share information and deliver results with a team.
Embrace a life-long learning mindset and take ownership of learning journey and build your own development planning.
A competitive remuneration package with a minimum salary of € 3.307,50 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
- Work @ home depending on the position / department
- 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
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.
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.
