Qualified Person

**Qualified Person (f/m/d), Tyrol, Kundl, Austria**

6 The number of generic Biopharmaceutical Medicinal Products manufactured, tested, and released on behalf of Sandoz. As a member of the team of Qualified Persons embedded in the newly formed External QA Operations Team at Sandoz Kundl manufacturing site, you will be crucial in supporting our mission to supply high quality Biopharmaceutical Medicinal Products to patients in more than 50 different countries worldwide.
- In this team you will help to ensure the continued supply of medicinal products throughout Austria specifically by supporting releases of medicinal products through the Local Austrian Country Quality Organization who is responsible for supplying 1500 different products to the patients in Austria.**Your key responsibilities**:
Your responsibilities include, but are not limited to:
- Batch release according to Annex 16 of Volume 4 of the EU GMP guidelines for human and veterinary medicinal products
- Support of the quality assurance team in the production area
- Checking and processing of complaints, deviations, OOS and change control
- Creation and improvement of quality systems and SOPs
- Review and approval of manufacturing instructions, test methods and specifications
- Creation, review, and approval of quality-related documentation, as well as risk analyses, product quality reviews (PQR)
- Participation in qualification and validation processes
- Participate in global team decisions on market actions to ensure patient safety services as needed
- Preparation, participation and follow-up of self-assessments, customer audits and official inspections
- Workload management, performance, and leadership support for specialist teams

**Commitment to Diversity & Inclusion**:

- 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**:
**Essential**:

- Education: Successfully completed scientific studies (e.g. pharmacy, chemistry, biology)
- Fluent knowledge of English, German desirable
- 3 years of experience in Quality Assurance from a GMP regulated pharmaceutical company with at least 2 years of experience in QC
- Excellent organizational and communication skills, independent working style and high decision-making quality
- Qualification as a Qualified Person according to AMG (Austrian Medicines Act))

**Desirable requirements**:

- Release as a QP of Biopharmaceutical Products for 1 year or more

**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 € 66.526,88/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.**Division**
- Novartis Technical Operations

**Business Unit**
- QUALITY

**Country**
- Austria

**Work Location**
- Kundl

**Company/Legal Entity**
- Sandoz GmbH

**Functional Area**
- Quality

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No