QA Operations Expert

Vor 5 Tagen

Kundl, Österreich Novartis Vollzeit

**Summary**:
Responsible for ensuring QA Operation activities in the area of responsibility are executed according to cGxP standards.

**About the Role**:
**Major accountabilities**:

- Oversight of all production & testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
- Participation in the preparation and approval of validations, transfer protocols/reports and SOPs
- Approval of specifications, instructions for sampling, testing methods, Production Master Batch Records and other procedures in the area of responsibility
- Support, elaboration and approval of investigations on deviations, OOS / OOE and Complaints; Evaluation and approval of CAPA measures and risk assessments
- Execution of batch release in compliance with cGxP and registration (in accordance with approval responsibility); participation in and evaluation of changes in the process and specifications; Collaboration in or management of project teams
- Participation in the preparation of Quality Assurance Agreements in line with Novartis Quality Manual & Policies; preparation and participation in audits and inspections; participation in and approval of APQR / APR
- Participation in and implementation of training Responsibility for release; Support OpEx improvement projects;
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt

**Minimum Requirements**:

- University degree in Engineering, Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent
- At least 3 years or more experience in QC or QA or medical device industry
- Experience in operations management and execution
- Preferably experience in negotiations and global collaboration
- Fluent knowledge of English and German language (written and spoken)
- Flexibility to work in a fast paced, quickly changing work environment
- Ability to operate in a global matrix environment
- English and 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 € 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

Kundl

Company / Legal Entity

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH

Functional Area

Quality

Job Type

Full time

Employment Type

Temporary (Fixed Term)

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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