Job Description Summary
QA Operations Expert (d/w/m), Kundl, Austria, Temporary for 2 yearsJob Description
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. By creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. The future is ours to shape!
Join us as our new QA Operations Expert and take the lead in driving quality excellence! In this role, you'll ensure that all operational activities in your area meet the highest standards—fully aligned with cGMP, the Quality Assurance Agreement, regulatory requirements, the Sandoz Quality Manual, and our Standard Operating Procedures.
Your Key Responsibilities:
Your responsibilities include, but not limited to:
- Oversight of supplier management and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
- Support exception investigations
- Review and approval of production, QC, and AS&T records
- Support OpEx improvement projects
- Reporting of technical complaints / adverse events / special case scenarios related to Sandoz starting materials
Key performance indicators:
- No Complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand.
- Successfully Support continuous improvement Projects
What you’ll bring to the role:
Essential Requirements:
- University degree in Natural Sciences (e.g., Chemistry, Pharmacy, Biotechnology, Biology).
- Expert knowledge of GMP
- Strong technical and regulatory understanding of quality assurance and manufacturing.
- Experience in Quality Assurance, with broader experience in QA/QC, Production, Supplier Management or related areas.
- Proficient in managing key quality processes, such as exceptions, complaints, batch reviews, QAA, QRA, APQR.
- Effective communicator and stakeholder manager, comfortable in matrix organizations.
- Languages:
- German (fluent) and
- English (fluent)
You´ll receive:
- Attractive salary with incentive program
- Modern company pension scheme
- Flexible working hours / home-office depending on the position
- 14 weeks of paid parental leave
- Additional days off (bridge-days)
- Subsidized meals in our canteen
- Sustainable mobility in the form of company transportation, shift buses and car sharing
- Company Kindergarden and summer camps for children
- Wellbeing & mental health offers
- Learning and development options for your personal and professional growth
- Worldwide career opportunities
In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is EUR 65.605,54/year (on a full-time basis).
In most cases, however, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provides more than 800 million patient treatments to over 700 million patients every year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit are powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
Are you ready to join us? Then we look forward to your application!
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and fostering diverse teams, that represent the patients and communities we serve.
If you require assistance during the application process due to a medical condition, physical disability, or a neurodiverse condition, please contact us at [email protected].
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talent Pool
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What We Do
Sandoz is the global leader in generic and biosimilar medicines. Our Purpose is to pioneer access to medicines for patients globally. We are on a mission to drive innovation in the healthcare industry by freeing up resources sustainably and responsibly while continuing to address global health challenges such as antimicrobial resistance. We are present in more than 100 countries and our medicines serve some 500 million people every year. We have two main global businesses: Generics - divided between standard generics and complex generics - and Biosimilars.
