Job ID
378551BR
Jul 12, 2023
Austria
Job Description
QA Operations Expert - Aseptic (d/f/m), Kundl, Austria
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?
100%! That is what everyone in the QA Operations team gives for our customers and patients. As QA Operations Expert (Aseptic) you will ensure that the quality and compliance requirements for our products are met. This is an effective way of ensuring that patients are supplied with high-quality medication.
Your key responsibilities:
Your responsibilities include, but are not limited to:
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?
100%! That is what everyone in the QA Operations team gives for our customers and patients. As QA Operations Expert (Aseptic) you will ensure that the quality and compliance requirements for our products are met. This is an effective way of ensuring that patients are supplied with high-quality medication.
Your key responsibilities:
Your responsibilities include, but are not limited to:
- Ensure within Oral solid dosage form and Sterile dosage form that from an environmental monitoring and/or an aseptic perspective, the manufacturing operation runs following its validated status, all SOPs, and Good Manufacturing Practices.
- QA aseptic oversight during sterile formulation and filling (Media Fill Testing, Smoke Testing)
- Manage Aseptic Process Qualification program and schedule qualifications for personnel.
- Participates to establish environmental monitoring plans (Oral and Sterile dosage forms) and frequency for Clean Utilities and cleanroom.
- Review quarterly EM trend reports and support identification of appropriate corrective and preventative actions as required.
- Identify risks and opportunities in relation to contamination control on the shop floor and drive follow up initiatives for improvement.
- Leading, writing or supporting production deviation investigations related to microbial contamination, CAPA proposal (Impact Assessments & Root Cause Analysis)
- Creation and improvement of quality systems and SOPs as well as creation, review 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:
Essential:
Desirable requirements:
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 €60,212.18/year (on a full time basis). In most cases, 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.
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
#Sandoz
Essential:
- Successfully completed academic studies of natural sciences (e.g. microbiology, pharmacy, chemistry, biology)
- Experience working in aseptic operations, vial and syringe filling
- Fluency in German and English
- 3 years of experience of microbiology/ sterility assurance or aseptic filling experience in a GMP-regulated pharmaceutical company
- Excellent organizational and communication skills, independent working style and high decision quality
Desirable requirements:
- Experience in a sterile production environment
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 €60,212.18/year (on a full time basis). In most cases, 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.
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
#Sandoz
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
