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(Senior) QA Operations Expert / Qualified Person (m/f/d)
Job ID 319911BR Position Title (Senior) QA Operations Expert / Qualified Person (m/f/d) Apply to JobJob Description
(Senior) QA Operations Expert / Qualified Person (f/m/d), STO Anti-Infectives FDF / Steriles, Kundl, Austria120 Million! This is the number of sterile vials 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 sterile 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!
Your key responsibilities:
Your responsibilities include, but are not limited to:
• Support of the Quality Assurance team within the production area
• Batch Record Review for the final release of products
• 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
Minimum requirements
What you’ll bring to the role:Essential:
• 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
Desirable requirements:
• Experience in a sterile production environment
You’ll receive: (not mandatory)
Flexible working time, competitive salary, a responsible working area in a dynamic team
Why Novartis?
769 million lives were touched by Novartis medicines in 2020, 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 € 51.180,50/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, colour, 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 Division Novartis Technical Operations Business Unit NTO QUALITY Location Austria Site Kundl Company/Legal Entity Sandoz GmbH Functional Area Quality Job Type Full Time Employment Type Regular Shift Work No