QA Operations Expert

vor 2 Wochen

Langkampfen T, Österreich Novartis Vollzeit

**Summary**:
QA Operations Expert is 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 and 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 and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
- On-time and GMP-compliant release of dosage forms
- Support exception investigations
- Review and approval of production, QC, and AS and T records and MBR review
- Support OpEx improvement projects Qualified Person
- Executes 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)
- Successfully Support continuous improvement Projects

**Essential Requirements**:

- KLL - Kontrollaborleiter(in) qualification required for the role
- At least 2 years' experience in QA or QC, testing and GMP procedures
- Background of aseptic manufacturing process
- Project Management and Operations Management and Execution
- Continuous Learning and dealing With Ambiguity
- Technological Expertise and Intelligence
- English and German language required

**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 € 64.023,54 /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

Innovative Medicines

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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