The core purpose of the position is to support quality activities related to oversight of Contract Manufacturing Operations (CMO) performed on behalf of Takeda.
- Responsible for batch review and coordination of product release activities at Takeda Services Contract Manufacturing Organizations (CMO) for both commercial and/or clinical products.
- Playing a key role in managing the CMO relationship, in particular to ensure completeness and compliance of records and documentation to ensure timely disposition of product
- Supporting any GMP, Quality and Compliance activities as required
- Preparing and reviewing batch disposition risk assessments and disposition documentation (eg. shipment authorization)
- Prepares reports and maintains quality metrics (in particular related to disposition processes) and makes recommendations to management
- Authoring, revising and/or reviewing Takeda’s Standard Operating Procedures, Guidance Documents, Technical/Quality Agreements, and other documents as assigned
- Assisting in the preparation of Annual Product (Quality) Reviews (APR/APQR), complaint investigations, change controls as assigned deviations
- Acting Quality Representative for projects
Your Skills and Qualifications:
- Minimum of 5 years experience in a QA/compliance related position within the pharmaceutical or life-sciences industry
- Knowledge and understanding of EU and US cGMP regulations with respect to the production and testing of pharmaceutical and/or biological products
- Strong track record of identifying and correcting compliance issues and implementing process improvements
- Demonstrated experience working with and preparing SOPs
- Clear experience working with/improving pharmaceutical Quality Management Systems
- Minimum requirement of a bachelor degree in Sciences or Engineering (Chemistry, Biology, Pharmacy, Microbiology, etc.)
- Ability to work on Quality projects where analysis of data requires evaluation of identifiable factors
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.
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 € 3.270,89 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.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.