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QA Operations Expert (m/f/d)

Job Description

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.

In the role, you will be responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements & the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures.

Your key responsibilities:
• Manage and drive forward OpEx improvement and QA PMO projects as project lead.
• Lead OpEx improvement and PMO QA projects as project manager.
• Performance of project adherence tracking of OpEx improvement and PMO QA projects.
• Financial accountability for OpEx improvement and PMO QA projects (business case, CAR, and purchase order process).
• Coordination of project activities with all involved departments (regulatory, production, QC, AS&T, QA etc.) as project lead, including all the needed reporting.
• Oversight of all production & testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance.
• Support exception investigations, review and approval of production, QC, and AS&T records and MBR review. Executing batch release in compliance with registration.

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 in Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent.
• Approx. at least 5 years or more of Project management experiences, prefferably in Operational Excellence, QA or QC.
• Experiences in operations management and execution.
• Prefferably experiences in negotiations and global collaboration.
• Fluent knowledge of English language (written and spoken), German is an advantage.
• Flexibility to work in a fast paced, quickly changing work environment.
• Ability to operate in a global matrix environment.

Possible job locations: Austria

You'll receive
Flexible working schedule, competitive compensation package, annual bonus, possibility to work from home and many other benefits, related to the legal entity you'll be employed at.

Why Novartis?
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 € 54.788,30/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 (relevant only for Austria).

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.

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

QA Operations Expert (m/f/d)

Langkampfen
Vollzeit

Veröffentlicht am 25.11.2022

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