QA Operations Expert (f/m/d), Kundl, Austria
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
What you'll bring to the role:
• 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
• Experience in a sterile production environment
766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
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 within the Novartis group. 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 € 54.788,3/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.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.
Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, color, race, sexual orientation, nationality or disability.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network