Senior QA Compliance Specialist

vor 2 Wochen


Langkampfen T, Österreich Novartis Vollzeit

**Senior QA Compliance Specialist (f/m/d), Schaftenau, Tyrol, Austria**

8 That is the number of experts who you will work with as part of our Quality Projects' Team As part of our larger QA Compliance Team, you will support us in implementing equipment and software improvements to our advanced continuous drug substance manufacturing facility. and thereby help us achieve the goal of making high-quality products available to patients all over the world. We are convinced: curious, ambitious and team-oriented people like you will find new answers together in an inspiring environment and make courageous decisions.**Your key responsibilities**:
Your responsibilities include, but are not limited to:
- QA responsibility for the qualification of equipment, equipment software, and utilities
- Review and approval of qualification documents
- QA Responsibility for deviations and changes
- Support the coordination and implementation of improvement projects
- Review and approval of SOPs
- Participation in and support for inspections and audits

**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**:

- Bachelor/Master's degree in Life Sciences or comparable
- Experience in the field of pharmaceuticals
- Proficiency in spoken and written English along with proficiency in German
- Confident handling of MS Office
- Accountability, motivation, and the ability to work as part of a team
- Very good communication skills

**Desirable requirements**:

- Experience of working in a GMP environment
- Background in project management

**Why Novartis?**

766 million lives were touched by Novartis medicines in 2021, 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 €49,804.58 per year (on a full time basis). We also offer a potential market oriented excess payment in line with your experience and qualifications.**Disabilities: Accessibility and Reasonable Adjustments**:
**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**
- 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**
- Yes



  • Langkampfen, T, Österreich Novartis Vollzeit

    386526BR **Senior QA Operations Specialist, Teilzeit (m/w/d)**: Austria **About the role** **Senior QA Operations Specialist, Teilzeit (m/w/d), Schaftenau, Tirol, Österreich** **Die Position**: 13 kommerzielle Produkte und ein geplanter Ausbau der DPS macht die Vielseitigkeit des Drug Product Produktionsstandorts in Schaftenau aus. **Ihr...


  • Langkampfen, T, Österreich Novartis Vollzeit

    **Senior QA Operations Specialist (m/w/d), NTO Quality, Schaftenau, Österreich** 300 Millionen! Das ist die Zahl der Menschen die weltweit unter den Folgen einer Autoimmunerkrankung leiden und von kostengünstigeren Arzneien profitieren würden. Als QA Operation Expert (w/m/d) in unserer innovativsten biopharmazeutischen Produktionsanlage helfen Sie diesen...


  • Langkampfen, T, Österreich Novartis Vollzeit

    **Senior QA Operations Specialist (m/w/d), Tirol, Schaftenau, Österreich** 13 kommerzielle Produkte und ein geplanter Ausbau der DPS macht die Vielseitigkeit des Drug Product Produktionsstandorts in Schaftenau aus. **Ihr Verantwortungsbereich**: Organisatorische Vorbereitungsaufgaben für die Qualitätssicherung für interne/externe Projekte;...


  • Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: The Complaint Specialist is responsible for performing complaint investigations (initial assessments, escalations, investigations and approval) and it is responsible for identifying improvements of complaints across all products. Additionally, there is the responsibility regarding the management of samples and all related activities. All these...


  • Langkampfen, T, Österreich Novartis Vollzeit

    **About the Role**: **Senior QA Operations Specialist (m/w/d), Drug Substance Schaftenau, Tirol, Österreich** **Die Position**: In dieser Rolle werden Sie in Quality Assurance Operations Team arbeiten und direkt an den Quality Team Lead von QA Operations berichten. **Ihr Verantwortungsbereich**: Ihre Aufgaben sind unter anderem: - Prüfung der Einhaltung...


  • Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: As Senior QA Compliance Expert you will support, facilitate and drive on-site regulatory CMC related launch and post-approval activities (post-approval changes, transfers, remediation, divestment, pruning and due diligence) of the Campus products to ensure timely supply to the markets in compliance with current regulatory obligations and...


  • Langkampfen, T, Österreich Novartis Vollzeit

    **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...


  • Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: ~Verwaltet Qualitätsaspekte und Projekte im Verantwortungsbereich. ~Gewährleistet und unterstützt die GxP-Konformität und die Einhaltung der Qualitätsmanagementsysteme von Novartis. **About the Role**: **Key Responsibilities**: - Implement, comply with, and govern practices prescribed in the Novartis Manufacturing Manual - Oversight of...

  • QA Senior Specialist

    Vor 5 Tagen


    Langkampfen, Österreich Novartis Pharma GmbH Vollzeit

    QA Senior Specialist (MiBi) 50% - Schaftenau, Tirol Teilzeit möglich Diversity-Statement Arbeitsplatz-Anpassungen möglich Überblick Erstellt mit künstlicher Intelligenz Summary ~管理责任范围内的质量方面和项目。 ~确保并支持整体GxP合规性和诺华质量管理体系的合规性。 About the Role Major Accountabilities ~

  • QA Operations Lead

    vor 1 Woche


    Langkampfen, T, Österreich Novartis Vollzeit

    **QA Operations Lead (f/m/d), Quality Large Molecules, Drug Product Schaftenau, Austria** Nr. 1! Take the lead in making Drug Product Schaftenau to be the nr. 1 fill finish site for biologics within Novartis Operations! A QA Operations Lead is responsible to ensure compliance to cGxP standards for our product portfolio and for product release as well as to...