As&t Expert

**Summary**:
Ensure analytical Life Cycle Management for commercial/existing products and ensure timely analytical implementation for new projects with focus on raw materials.

Responsible for managing all analytical aspects with focus on raw material 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.

**About the Role**:
**Your responsibilities include, but are not limited to**:

- Management and oversight of all analytical activities related within responsible projects with focus on raw material analytics
- Ensure timely analytical implementation (Method Transfer and Method Validation) for raw material testing for new projects in the course of product transfers
- Single point of contact for internal and external clients and contract laboratories with focus on raw material analytics
- Scientific analytical support for quality control, production, registration and marketing
- Life-cycle management of analytical methods with focus on raw materials, including control of method performance, analytical method improvements, pharmacopoeia and health authority compliance
- Subject matter expert in health authority inspections and Customer Inspections
- Budget planning and budget tracking; support overarching product investigations cross functional, e.g. QC, QA, Production, MS&T
- Implementation of GMP requirements. Compilation and review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents)

**Essential Requirements**:

- Ph.D. in chemistry of biochemistry or at least 5 years of experience within pharmacy in project management of operational manager
- Analytical Expertise, preferably for raw materials
- Knowledge of GMP
- Project Management
- Raw Material Testing according to Ph.Eu. and USP
- Quality Focus, Project Focus, Accountability and Result Driven
- Team Player able to make decisions, strong in Digital & Technical
- fluent English or German language

**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

Innovative Medicines

Location

Austria

Site

Kundl

Company / Legal Entity

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH

Functional Area

Quality

Job Type

Full time

Employment Type

Befristet (Befristet)

Shift Work

No

**Unterstützungen für BewerberInnen mit Behinderungen**: