As&t Expert

Vor 2 Tagen

Langkampfen T, Österreich Novartis Vollzeit

**Summary**:
Responsible for managing all analytical aspects with focus on Medical Devices and functional testing within responsible projects 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. Ensure analytical Life Cycle Management for commercial products and ensure timely analytical implementation for new projects.

**About the Role**:
**Key Responsibilities**:

- Technical SME for device related analytical methods and functional testing equipment (e.g. ZwickRoell test machines)
- Management and oversight of all analytical activities related within responsible projects (functional testing of devices)
- Life-cycle management of analytical methods, including control of method performance, analytical method improvements, pharmacopoeia and health authority compliance
- Ensure timely analytical implementation (Method Transfer and Method Validation) for (new) projects during product transfers
- Single point of contact for internal and external clients and contract laboratories
- Scientific analytical support for quality control, production and registration; Subject matter expert in health authority inspections
- Support overarching product investigations (Deviations and OOx) cross functional, e.g. QC, QA, Production, MS&T
- Implementation of GMP requirements. Compilation and review of documents (analytical protocols and reports, ongoing process verification reports, registration documents)

**Essential Requirements**:

- University degree or FH with natural science/technical background (e.g. engineering, metrology, chemistry, pharmacy,) or equivalent education
- Approx. 3 to 5 years in pharmaceutical industry and/or analytical laboratory in GMP environment
- MS Office
- Fluent in English and German

**Benefits and Rewards**:
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 € 65.605,54 /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 and Inclusion / EEO paragraph**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

**Accessibility and Accommodation**:
**Why Novartis**:
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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