Qc Specialist Ii
vor 5 Monaten
**Summary**:
We are looking for a highly skilled and experienced laboratory professional who will contribute to performing analytical reviews, scientific and investigational support, research support and stability testing.
**About the Role**:
**Major accountabilities**:
- Handling of OOx cases and Deviations
- Implementing changes and supporting transfers
- CAPA definition and preventative actions
- Contribution to the KPIs and operational excellence
- Ensuring all activities are in compliance with cGxP, incl. data integrity review and approval of analytical data / tests (analytical release), stability testing.
- Preparation of SOPs, protocols, laboratory procedures and evaluation reports.
- Performance of Stability studies, protocols and comparative reports for supplier qualification
- Providing expert support for site qualification and validation activities
- Supporting supplier qualifications and maintain equipment incl. plan preparation
- Supporting sample planning and test execution
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
**Skills**:
- Continuous Learning.
- Dealing With Ambiguity.
- Solution oriented
- Flexible and resilient working
- Good analytical thinking and scientific support for the QC operations Experience in coordination, and coordination of internal and external stakeholders.
**Minimum Requirements**:
- Completed studies in the field of Process Engineering, Biotechnology, Biology, Pharmaceutical Technology, Technical Chemistry (or comparable studies), min. Bachelor's degree with 5 years of work experience or Master's degree with 2 years of work experience.
- Experience in the pharmaceutical industry, preferably analytical laboratory testing of large molecules or development. Good GxP knowledge. Proficiency in English and German (spoken & written).
**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 €54.735,38/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 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.
**Why Novartis?**
**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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