QA Operations Expert
Vor 2 Tagen
**QA Operations Expert (f/m/d), Quality, Schaftenau, Austria**
In 2014 the first medical device was introduced to the market by Novartis/Sandoz, since then the portfolio for medical devices and combination products are heavily growing. Be part of the QA Medical device team and support commercialization of new devices to the markets worldwide.
- As part of our team, you will be supporting introduction of new autoinjector devices to commercial phase and manage the device suppliers from a quality point of view. 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**:
Your responsibilities include, but are not limited to:
- Oversight of all production & testing activities, ensuring compliance with cGxP, incl. data integrity and eCompliance
- Support exception investigations
- Review and approve of production, QC, and AS&T records
- MBR review
- Support OpEx improvement projects Qualified Person - execute batch release in compliance with registration
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
- Distribution of marketing samples (where applicable)
- Responsible for third party management of device component suppliers
- Review and approval of DHF and DMR documents for Commercial medical devices and combination products
**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**:
- University degree in Engineering, Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent
- At least 3 years or more experience in QC or QA or medical device industry
- Experience in operations management and execution
- Preferably experience 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
**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 € 54,788.3 /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.**Division**
- Novartis Technical Operations
**Business Unit**
- QUALITY
**Country**
- Austria
**Work Location**
- Schaftenau
**Company/Legal Entity**
- Sandoz GmbH
**Functional Area**
- Quality
**Job Type**
- Full Time
**Employment Type**
- Regular
**Shift Work**
- No
**Early Talent**
- No
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