- Management of global Product (e.g. Intermediates, Drug Substances and Drug Products), Plasma and Cell Bank Specification Documents
- Create/revise/merge/obsolesce specification documents in the data document quality system
- Interface between Product Quality Lead and PLCM
- Assessment/planning/managing of Specification related Change Controls
- Responsible for timely closure of all Change Control related actions and the respective Change Controls
- Support any harmonization and integration activities; Support in reduction and simplification activities according to continuous improvement methodology
- Masters degree (scientific or engineering) preferred
- 2-3 years of related work experience in the pharmaceutical industry
- Prior experience working in global teams is preferred
- Experience in change control and specification management highly preferred
- Expertise in GMP regulations and compliance requirements in product life cycle
- Understanding of GDP
- Project Management experience is a bonus
- Fluency in German and English
As a leading global biotechnology company we have one mission every day: to lastingly improve the lives of people living with rare diseases. Crucial to our mission are our employees - our biggest asset - who enjoy a range of benefits and career opportunities, such as trainee and training programs, job rotations, apprenticeships, work-life balance (certified family friendly), company kindergarten, wellness center, cafeteria, etc. Here you can learn more about Shire in Austria.
We offer outstanding opportunities to motivated people regardless of your gender, age, skin color, ethnicity, sexual orientation or physical handicaps. Diversity is part of our success!
The minimum salary for this position is € 3.163,33 gross per month (full-time); increased payment is possible. We are looking forward to your application.