QA Operations Expert
vor 7 Monaten
**Summary**:
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.
**About the Role**:
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
- 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 and primary packaging material suppliers
- Review and approval of DHF and DMR documents for Commercial medical devices and combination products
Essential Requirements:
- University degree in Engineering, Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent
- At least 3 years or more experience in MS&T, 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?
You’ll receive:
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities 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 € 60.600 /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.
We are open for part-time and job-sharing models and support flexible and remote working where possible.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve.
Adjustments for Applicants with Disabilities:
Join our Novartis Network:
Division
Operations
Business Unit
Pharmaceuticals
Location
Austria
Site
Schaftenau
Company / Legal Entity
AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No
**Adjustments for Applicants with Disabilities**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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