Senior QA Operations Specialist

**Senior QA Operations Specialis (f/m/d), Schaftenau/Tyrol, Austria**

**Your key responsibilities**:

- Review and approval of executed batch records (BRs) and GMP-related documents that are directly or indirectly linked to the executed BRs
- Review and approval of qualification activities of the electronic BR system
- Implement, comply with, and govern practices prescribed in the Novartis Manufacturing

Manual
- Formal checks of master batch records (MBRs) in Condor
- Oversight of GxP functions across site and ensure product quality
- Ensure regulatory compliance and implementation of corporate quality standards and

regulations
- Ensure qualified state of facilities and utilities
- Ensure exception (deviation and OOX) handling and complaint management and investigation

**Commitment to Diversity & Inclusion**:

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

**Minimum requirements**

**What you’ll bring to the role**:

- Finalized apprenticeship in an area of the Pharmaceutical industry (e.g. chemical laboratory worker, chemical worker or related fields / internal specific education (‘Modulausbildung’)
- At least 2 years experience in Pharmaceuticals, Biopharmaceutical or API products (QA, QC, production or related fields) and thorough knowledge of cGMP requirements
- Knowledge of GMP
- Knowledge of IT Applications & tools
- Very strong communication skills in German and English

**Why Novartis?**

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying

**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. 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). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

**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.

**Join our Novartis Network**:
**Division**

Operations

**Business Unit**

QUALITY

**Country**

Austria

**Work Location**

Schaftenau

**Company/Legal Entity**

Sandoz GmbH

**Functional Area**

Quality

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No