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As a Quality Specialist, you will support the Quality- area of Distribution and Sales for Austria 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.
Maintain the LOC QMS including coordination of Gap Assessments of global processes.
Create and maintain local SOPs and other quality relevant documents (e.g. contracts, quality agreements).
Manage and support local deviations and CAPAs, support escalations and field corrective actions
Local quality surveillance - connects with customers: returns, market actions, complaints, inquiries, customer qualification.
Participation in internal and external audit.
Participation in preparation of monthly reporting of LOC Quality.
Support health authority communications on product quality issues affecting the country.
Enterprise thinking, finding innovative ways to serve patients, build reputation and trust.
Participate in LOC, GQ projects as assigned by Line Manager.
Bachelor or Master 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.
Fluency in spoken and written German and English.
Communication and organization skills.
Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, work together as 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.
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.
