Feb 25, 2022

Job Description

Qualified Person (f/m/d), NTO, Schaftenau, Austria

6 and 3! The number of generic and innovative Biopharmaceutical Medicinal Products manufactured, tested, and released on behalf of Sandoz and Novartis. As member of the team of Qualified Persons embedded in the Quality Unit of a leading Novartis manufacturing site for Biopharmaceuticals, you will be crucial in supporting our mission to supply high quality Biopharmaceutical Medicinal Products to patients in more than 50 different countries worldwide.

Your key responsibilities:
Your responsibilities include, but are not limited to:
• Release of batches in accordance with Annex 16 of Volume 4 of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
• Consultation with health authorities for quality related topics
• Support of the Quality Assurance team within the production area
• Evaluation and approval of complaints, deviations, OOS investigations and change controls
• Creation and improvement of quality systems and SOPs
• Review of manufacturing instructions, testing methods and specifications
• Review and approval of risk analyses and product quality reviews, involvement in qualification and validation processes
• Creation, assessing and approval of quality-relevant documentation
• Preparation, participation in and follow-up of self-inspections, customer audits and authority inspections
• If needed, participation in global teams deciding on market actions to assure patient safety

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:
• Successfully completed academic studies of natural sciences and qualification as Qualified Person (Sachkundige Person) in accordance with AMG (Austrian Medicines Act)
• Fluency in English, working knowledge in German is beneficial
• 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-making quality

Desirable requirements:
• Team player who likes to share her/his experience and knowledge
• Curious and flexible person who always aims for the better

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 € 63.388,92/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.

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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Qualified Person (f/m/d)

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