Your (new) Opportunity:
- Represent Site Quality Orth in Product Development and New Technology Implementation Projects
- Align activities based on minimum Quality requirements for different product development phases (Clinical Phase I - III)
- Simplify and reduce complexity in Quality Systems to ensure compliance and efficiency in manufacturing and testing of material for clinical supply
- Cooperate with project interfaces to coordinate tasks to achieve Quality Milestone fulfillment
- Act as Subject Matter Expert for Quality System requirements during the manufacturing and testing of development products
- Support ongoing continuous improvement activities within the site
- Lead selected Quality & Compliance projects
- Perform active knowledge management within the site
- Act as Lead Auditor in the Site Self Inspection Program, responsible for the preparation and performance of self-inspections as well as the creation of an audit report and the evaluation and approval / rejection of audit response incl. proposed CAPAs
Your Skills and Qualifications:
- University degree in natural sciences or equivalent technical discipline required, ideally in Biochemistry, Biotechnology or Pharmacy
- Thorough knowledge and capability of interpretation and applicability of GxP regulations and standards, internal GxP guidelines, cGMP 21 CFR 210/211/600/820 and Eudralex Volume 4 GMP guidelines, ICH Quality guidelines, USP and European Pharmacopeia
- Strong experience in Quality Assurance and/or Quality Control
- Profound biotechnological and/or pharmaceutical understanding
- Audit experience is highly advantageous
- Ability to create an environment that inspires and enables people
- Experience through interacting and collaborating with global teams; project/program management preferred
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work - life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer. For more insights into Takeda click here.
We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.
Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position is € 4 527,78 gross per month (full time, collective wage agreement for the chemical industry). The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.
AUT - Orth an der Donau