QA Compliance Expert

vor 2 Wochen

Kundl, Österreich Sandoz GmbH Vollzeit

**QA Compliance Expert (d/f/m), Kundl, Tyrol, Austria**

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our ‘new’ Sandoz

Our B2B business is serving hundreds of customers with High Quality products manufactured by Sandoz and Partners. One of our key responsibilities within our Quality Compliance Team is to drive the Good distribution Practices within the B2B Business. We are looking for a QA Compliance expert to actively create and live a dynamic setup that is currently in that area.

**Your key responsibilities**:
Your responsibilities include, but are not limited to:

- Being the GDP responsible person for Sandoz B2B Business
- Fulfilling tasks and responsibilities according to global and local GDP regulations for APIs and finished products
- Contractor management tasks
- Leading authority inspections
- SOP review and authorship
- Quality agreement creation, maintenance and compliance status monitoring of customers and suppliers
- Quality Oversight of the business, warehouses and logistics
- Communicate and drive decision making within internal and external parties

Diversity and Inclusion
- We are 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**:
**Essential**:

- Master degree or higher in Pharmacy, Medicine, Chemistry, Biology, Biotechnology or Nutrition technology within EEA or Switzerland
- Minimum of one year (preferred 3 years) experience in a company holding a wholesaling license or Fulfilling Austrian Regulations (AMBO) requirements for Fachkundige Person / GDP responsible person
- Strong GxP mindset
- Fluency in English and German
- Experience in handling of complaints and deviations

**Desirable requirements**:

- Experience working with SAP / 1QEM / Trackwise
- Experience with Quality Agreements
- Experience with Dangerous Goods Declarations

**Why Sandoz?**

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

The future is ours to shape

**Imagine what you could do here at Sandoz**

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. 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 € 60,212.18/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. We are open for part-time and job sharing models and support flexible and remote working where possible.

Sandoz
- Division
- SANDOZ
- Business Unit
- Quality STO
- Location
- Austria
- Site
- Kundl
- Company/Legal Entity
- Sandoz GmbH
- Functional Area
- Quality
- Job Type
- Full Time
- Employment Type
- Regular
- Shift Work
- No

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