May 25, 2022

Job Description

Senior Core Quality Compliance (f/m/d), Novartis Technical Operations, Kundl, Austria

160 Million! This is the number of antibiotics packs that we produce in Kundl and deliver to patients in more than 80 countries all over the world in a year! Your role will be to ensure that the site maintains alignment with the local legislation (AMBO), EU directives and FDA guidelines. You will be working in a multi-disciplinary team of Compliance Experts servicing an end to end Anti-Infectives Manufacturing Operation starting from the Active Pharmaceutical Ingredient and continuing to the Finished Dosage Form.

Your key responsibilities:

Your responsibilities include, but are not limited to:

• Participating in cross-contamination control activities related to Anti-biotic manufacturing on the local Campus.
• Coordination of Data Integrity related activities across the Anti-Infectives Sites in all departments involved in the Make Test Release process.
• Creation and quarterly monitoring of a Site Quality Plan that governs the implementation of Global and Local Events and actions related to Site Operations
• Monthly setup of a Quality Governance Board that provides insights into the Quality Performance of the site, this includes detailed KPI analysis, reporting and mitigation of activities required to address Quality related Challenges
• Creation of Risk Assessments supporting Quality Assurance Investigations
• Participation on behalf of QA Compliance in the investigation teams of Critical or Major Product and Non-Product related Deviations, Market Product Complaints, and Laboratory Out of Specification investigations.
• Management of the Global Quality Escalation process for the local Anti-Infective sites, this includes participation and coordination of all Global QA calls related to Incident Management
• QA Review of Equipment Qualification documentation for Quality Control Laboratories, Microbiological Laboratories and Manufacturing areas
• Coordination of regular GMP walkthroughs in various areas within the site
• Participation in GMP & Continuous Improvement Projects

Diversity & Inclusion / EEO

Novartis is 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:
• University degree or equivalent qualification/experience in a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)
• Experience in Quality Assurance or Quality Control in a manufacturing environment within the pharmaceutical industry, preferably in sterile manufacturing (Qualified Person according to EU directive 2001/83/EC status preferred)
• Fluent (oral and written) in English and German
• Deep understanding and working knowledge of the global Novartis Quality Management system and processes

Desirable requirements:
• Qualified Person according to EU directive 2001/83/EC status preferred
• Sterile manufacturing experience
• QC experience

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 € 52.204/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.

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
Novartis Technical Operations
Full Time
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Quality Compliance Expert (f/m/d)

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