QA Operations Expert

Vor 2 Tagen

Stein, Schweiz Novartis Vollzeit

300 Million. This is the number of people suffering from autoimmune diseases worldwide. Join our team as QA Compliance Manufacturing Manager (f/m) in our most advanced biopharmaceutical production and help to improve their lives.

A QA Operations Expert performs a compliant and timely release of dosage forms according to applicable local and international requirements as a technical responsible person (eg. Qualified Person or equivalent), provides quality oversight and expert support in the evaluation and execution of complex investigations and changes.

MAJOR ACCOUNTABILITIES

Operational
- Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
- Support exception investigations (complex/critical)
- Support change control activities relating to complex changes
- Support OpEx improvement projects
- Execute batch release in compliance with registration according to local requirements as technical responsible person (eg. Qualified Person or equivalent)

HSE
- Comply with all HSE guidelines
- Detect and report potential accident, risks and propose solutions
- Participate in HSE risk assessments
- Preparation and participation to internal HSE audits
- Responsible for participating in initial training and retraining

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**
- Experience in pharmaceutical quality control, quality assurance or production and manufacturing
- Experience in Operations Management and Execution; Functional Breadth; Collaborating across boundaries; Applied Practice
- Good (oral and written) in English; fluent in German (oral and written)
- Collaboration; result-oriented
- Good knowledge of GMP; Continuous Learning; Operational Excellence; Digital & Tech Savvy

Desirable requirements:

- Good knowledge of SAP
- University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)

You’ll receive:
We offer you a challenging, international and interdisciplinary work environment. Investment in people is a priority for Novartis. We offer a range of possibilities for personal development and career opportunities within the group to motivated, qualified people. We offer you a competitive salary and benefit package. Novartis also supports a flexible work-life integration (working remotely, flexi-time schedules,...). Locally, we offer benefits to ensure our associate's mental and physical well-being. There is a fitness available for our associates to use and we offer a bike-leasing program. We have a mental coach on site as well.

Why consider Novartis?

769 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis

**Division**

Novartis Technical Operations

**Business Unit**

NTO QUALITY

**Country**

Switzerland

**Work Location**

Stein (Säckingen)

**Company/Legal Entity**

Novartis Pharma AG

**Functional Area**

Quality

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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