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Job ID
377053BR
Jun 28, 2023
Austria
Job Description
Senior QA Operations Expert / Qualified Person (d/f/m), Kundl, Tyrol, Austria
135 Million! This is the number of oral products that we produce in FDF Kundl and deliver to patients in more than 80 countries all over the world in a year! As QA Operations Expert / Qualified Person, you will be taking on a highly responsible role through securing that all our oral products adhere to the highest GMP standards. Hereby you ensure that our patients receive the high-quality medicine which improves and extends their lives. Apply now to become a part of our dynamic team!
2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!
Together we will shape the future of Sandoz… are you ready to make a difference?
Your key responsibilities:
Your responsibilities include, but are not limited to:
135 Million! This is the number of oral products that we produce in FDF Kundl and deliver to patients in more than 80 countries all over the world in a year! As QA Operations Expert / Qualified Person, you will be taking on a highly responsible role through securing that all our oral products adhere to the highest GMP standards. Hereby you ensure that our patients receive the high-quality medicine which improves and extends their lives. Apply now to become a part of our dynamic team!
2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!
Together we will shape the future of Sandoz… are you ready to make a difference?
Your key responsibilities:
Your responsibilities include, but are not limited to:
- Ensure that all products manufactured by site/External Supplier in addition to the imported products for local site are released to the market according to Sandoz Quality Standards.
- Oversight of Quality Operations across site.
- Review and approval of Master batch records
- Support of the Quality Assurance team within the production area
- Evaluation and processing of complaints, deviations, OOS and change control
- Creation and improvement of quality systems and SOPs
- Review of manufacturing guidelines, testing methods and specifications
- Conduction of risk analyses and product quality reviews, involvement in qualification and validation processes
- Creation, testing and approval of quality-relevant documentation
- Preparation, participation in and follow-up of self-inspections, customer audits and authority inspections
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum Requirements
What you’ll bring to the role:
Why Sandoz?
Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Imagine what you could do here at Sandoz!
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as 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 € 73,112.90 EUR /year (on a full time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.
We are open for part-time and job sharing models and support flexible and remote working where possible.
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: https://talentnetwork.novartis.com/sandoztalentpool
- Education: Successfully completed academic studies of natural sciences and qualification as Qualified Person (Sachkundige Person) in accordance with AMG (Austrian Medicines Act)
- Fluency in English, good working knowledge in German
- 3 years of experience in the Quality Assurance area of a GMP-regulated pharmaceutical company
- Excellent organizational and communication skills, independent working style and high decision quality
Why Sandoz?
Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Imagine what you could do here at Sandoz!
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as 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 € 73,112.90 EUR /year (on a full time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.
We are open for part-time and job sharing models and support flexible and remote working where possible.
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: https://talentnetwork.novartis.com/sandoztalentpool
Division
SANDOZ
Business Unit
Quality STO
Location
Austria
Site
Kundl
Company / Legal Entity
Sandoz GmbH
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
No
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