QA Compliance Expert (m/f/d)

Aug 09, 2021

Job Description

QA Compliance Expert (f/m/d), Anti-Infectives FDF, Sandoz Technical Operations (STO), 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!
As QA Compliance Expert (f/m/d), your role will be to ensure that all of this happens in alignment with the local legislation (AMBO), EU directives and FDA guidelines.

Your key responsibilities:

Your responsibilities include, but are not limited to:
• Act as “Fachkundige Person” [FKP] according to AMBO on behalf of Sandoz Technical Operations (An FKP is the Person responsible, from a Quality Assurance perspective, to ensure that the Wholesale Business is operating in alignment with EU regulations)
• Act and Lead in a matrix organization involving various departments within Novartis and externally
• Maintenance of a Wholesale Quality System (SOP creation and update, investigation of related complaints and deviations in TrackWise and usage of other quality system tools as required)
• Release batches for distribution to clients and uploading of documentation in the relevant IT systems for record keeping
• Ensure API & FDF Wholesale Business operates within Compliance and provide oversight of the release process of various products (maintain and update customer lists, suppliers list, certifications, quality agreements etc.)
• Provide routine updates for the Quality Governance Board of wholesale activities
• Create quality agreements for clients and suppliers involved in the wholesale business of Anti-Infectives
• Hosting of health authority inspections and client audits, backoffice management, CAPA Follow-ups (FDF, API)

Minimum Requirements

What you’ll bring to the role:
• Master degree or higher in Pharmacy, Medicine, Chemistry, Biology, Biotechnology or Nutrition technology within EEA or Switzerland
• Minimum one, preferrable three years of experience working in a quality role (or related) in the pharmaceutical industry for a company which holds a wholesaling license (or better)
• Familiarity with the IT systems used in the pharmaceutical industry (e.g. TrackWise, SAP, Salesforce)
• Fluency in German and English
• Strong communication skills and political acumen

Desirable requirements:
• Experience in the creation of quality agreements
• Previous experience as “Fachkundige Person” according to AMBO

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

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