Quality Team Leader QA Operations
Vor 3 Tagen
**Quality Team Leader QA Operations (f/m/d), Tyrol, Kundl, Austria**
100% That is what everyone in the QA Operations team gives for our customers and patients. As Quality Team Leader QA Operations you will ensure that the quality and compliance requirements for our products are met. This is an effective way of ensuring that patients are supplied with high-quality medication.**Your key responsibilities**:
Your responsibilities include, but are not limited to:
- Team Lead QA Operations Release group
- Responsibilities of a Qualified Person (QP)
- Responsibility for coordination and implementation of all release processes and release prerequisites (MBRs, changes, FDF submissions)
- Support of coordination of Sandoz Transformation Projects according QA requirements
- Tracking of regulatory status for transformation and launch products
- Creation, review, oversight and approval of reports for investigations, deviations, OOS/OOE/OOT and quality events and complaints
- QA role in 1QEM and AGILE
- Participation in audits performed by authorities or customers and in self-inspections
- Ensuring good collaboration with relevant departments (QC, stability, registration, production, MS&T etc.) as contact person for work group
- Organization/compilation of SOP’s relevant for department
**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**
**What you’ll bring to the role**:
**Essential**:
- Education: Successfully completed academic studies of natural sciences (e.g. pharmacy, chemistry, biology)
- Fluency in German and English
- 3 years of experience in the Quality Assurance area of a GMP-regulated pharmaceutical company
- Excellent organizational and communication skills, independent working style and high decision quality
- Basic understanding of SAP and 1QEM
- Experience as a Qualified Person
**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 and development options as well as worldwide career opportunities 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 € 66.526,88/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.**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.**Division**
- Novartis Technical Operations
**Business Unit**
- NTO QUALITY
**Country**
- Austria
**Work Location**
- Kundl
**Company/Legal Entity**
- Sandoz GmbH
**Functional Area**
- Quality
**Job Type**
- Full Time
**Employment Type**
- Regular
**Shift Work**
- No
**Early Talent**
- No
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