QA Operations Expert

vor 5 Monaten


Kundl, Österreich Novartis Vollzeit

389521BR

**QA Operations Expert (f/m/d)**:
Austria

**About the role**

**QA Operations Expert (w/m/d), Kundl, Austria**

As a QA Operations Expert you will be crucial in supporting our mission to supply more than 22 different high quality Biopharmaceutical Products to patients worldwide.

**Your Responsibilities**:

- Oversight of all production & testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
- Support and perform investigations in course of OOS and Deviation handling as QA
- Review and approval of production, QC, AS&T and MS&T records and SOPs
- Review of Master Batch Records
- Support OpEx improvement projects
- Executes batch release in compliance with registration
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt

**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._

**Role Requirements**

**Your Profile**:

- 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

**Why Novartis?**

**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 € 60,212.18/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. 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 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

**Work Location**

Kundl

**Company/Legal Entity**

NVS Pharmaceutical Manu. GmbH

**Functional Area**

Quality

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

Yes


  • QA Operations Expert

    vor 1 Monat


    Kundl, Österreich Novartis Vollzeit

    **Summary**: QA Operations Expert ensures 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...

  • QA Operations Expert

    vor 5 Monaten


    Kundl, Österreich Novartis Vollzeit

    385834BR **QA Operations Expert (f/m/d)**: Austria **About the role** **QA Operations Expert (w/m/d), Kundl, Österreich** As a QA Operations Expert you will be crucial in supporting our mission to supply more than 22 different high quality Biopharmaceutical Products to patients worldwide. **Your Responsibilities**: - Oversight of all production &...

  • QA Operations Specialist

    vor 5 Monaten


    Kundl, Österreich Novartis Vollzeit

    **Summary**: More than 20 products - our pipeline of Biologics, Biosimilars, Oligonucleotides and Originator products is continuously growing and need to be established and commercialized on the markets worldwide. We are looking for an experienced Senior QA Specialist (M/F/d) to join our team in Kundl. Be part of an important QA Group releasing products with...

  • QA Operations Specialist

    vor 5 Monaten


    Kundl, Österreich Novartis Vollzeit

    **Summary**: Location: Kundl, Tyrol, Austria, Hybrid Working #LI-Hybrid More than 20 products - our pipeline of Biologics, Biosimilars, Oligonucleotides and Originator products is continuously growing and need to be established and commercialized on the markets worldwide. We are looking for an experienced QA Operations Specialist (M/F/d) to join our team in...

  • QA Operations Specialist

    vor 5 Monaten


    Kundl, Österreich Novartis Vollzeit

    393582BR **QA Operations Specialist**: Austria **About the role** x **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._ **Role Requirements** x **Division** Operations **Business Unit** QUALITY **Work...

  • QA Compliance Expert

    Vor 2 Tagen


    Kundl, Österreich Novartis Vollzeit

    **Summary**: QA Compliance Expert (m/w/d) Location: Kundl, Tirol, Österreich #LI-Hybrid 40 Jahre! So lange werden an der Site “Drug Substance Kundl" erfolgreich Proteine mit mikrobieller Fermentation hergestellt. Zusätzlich wurde in den vergangenen Jahren in einer neuen Produktklasse Fuß gefasst: Nukleinsäuren z.B. für den zell - und...

  • QA Compliance Expert

    vor 5 Monaten


    Kundl, Österreich Novartis Vollzeit

    393594BR **QA Compliance Expert - Reg CMC Facilitator**: Austria **About the role** **QA Compliance Expert - Reg CMC Facilitator** Supporting product maintenance, and activities throughout the product life-cycle using regulatory strategies and documents related to CMC (Chemistry, Manufacturing & Control). This applies to sector-specific (global and...


  • Kundl, Österreich Novartis Vollzeit

    **Summary**: QA Operations Team Leader ensures that QA Operation activities in the area of responsibility are executed according to cGxP standards. **About the Role**: **Key Responsibilities**: - Oversight of all production & testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance; Review and approval of protocols, reports,...

  • QA Operations Specialist

    vor 5 Monaten


    Kundl, Österreich Novartis Vollzeit

    393584BR **QA Operations Specialist (M/F/d)**: Austria **About the role** **QA Operations Specialist (M/F/d), Kundl** More than 20 products - our pipeline of Biologics, Biosimilars, Oligonucleotides and Originator products is continuously growing and need to be established and commercialized on the markets worldwide. We are looking for an experienced...

  • QA Operations Specialist

    vor 5 Monaten


    Kundl, Österreich Novartis Vollzeit

    **About the Role**: **QA Operations Specialist (M/F/d), Kundl** More than 20 products - our pipeline of Biologics, Biosimilars, Oligonucleotides and Originator products is continuously growing and need to be established and commercialized on the markets worldwide. We are looking for an experienced Senior QA Specialist (M/F/d) to join our team in Kundl. Be...


  • Kundl, Tirol, Österreich Novartis Vollzeit

    Job SummaryAs a QA Operations Team Leader at Novartis, you will be responsible for ensuring that QA Operation activities in the area of responsibility are executed according to cGxP standards. This includes oversight of all production & testing activities, ensuring compliance with cGxP, incl. data integrity and eCompliance; review and approval of protocols,...

  • QA Operations Specialist

    vor 5 Monaten


    Kundl, Österreich Sandoz GmbH Vollzeit

    **QA Operations Specialist (d/w/m), Kundl, Tirol, Österreich** Sandoz befindet sich in einer spannenden und transformativen Phase als weltweit führender und bahnbrechender Anbieter von nachhaltigen Generika und Biosimilars. Als unabhängiges börsennotiertes Unternehmen will sich Sandoz stärker strategisch ausrichten, flexibler agieren, klarere...

  • QA Compliance Expert

    vor 5 Monaten


    Kundl, Österreich Sandoz GmbH Vollzeit

    **QA Compliance Expert (d/f/m), Kundl, Tyrol, Austria - Part-Time 75%** Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer...

  • QA Compliance Expert

    vor 5 Monaten


    Kundl, Österreich Sandoz GmbH Vollzeit

    **QA Compliance Expert (d/f/m), Kundl, Tyrol, Austria** Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives,...


  • Kundl, Österreich Sandoz GmbH Vollzeit

    **Senior QA GMP Facilitator II (d/w/m), Kundl, Österreich** Sandoz befindet sich in einer spannenden und transformativen Phase als weltweit führender und bahnbrechender Anbieter von nachhaltigen Generika und Biosimilars. Als unabhängiges börsennotiertes Unternehmen will sich Sandoz stärker strategisch ausrichten, flexibler agieren, klarere...

  • QA Gmp Facilitator Ii

    vor 5 Monaten


    Kundl, Österreich Sandoz GmbH Vollzeit

    **QA GMP Facilitator II (d/w/m), Kundl, Österreich** Sandoz befindet sich in einer spannenden und transformativen Phase als weltweit führender und bahnbrechender Anbieter von nachhaltigen Generika und Biosimilars. Als unabhängiges börsennotiertes Unternehmen will sich Sandoz stärker strategisch ausrichten, flexibler agieren, klarere Geschäftsziele...


  • Kundl, Tirol, Österreich Novartis Vollzeit

    Job Description SummaryAs a Quality Assurance Operations Expert at Novartis, you will be responsible for ensuring that all production and testing activities in your area of responsibility are executed according to cGxP standards. This includes oversight of all production and testing activities, ensuring compliance with cGxP, including data integrity and...

  • QA Gmp Facilitator I

    vor 5 Monaten


    Kundl, Österreich Sandoz GmbH Vollzeit

    **QA GMP Facilitator I (d/w/m), Kundl, Österreich** Sandoz befindet sich in einer spannenden und transformativen Phase als weltweit führender und bahnbrechender Anbieter von nachhaltigen Generika und Biosimilars. Als unabhängiges börsennotiertes Unternehmen will sich Sandoz stärker strategisch ausrichten, flexibler agieren, klarere Geschäftsziele...

  • QA Operations Specialist

    vor 6 Monaten


    Kundl, Österreich Novartis Vollzeit

    **About the Role**: x **Diversity & Inclusion / EEO**: - Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve._ **Role Requirements**: x Division Operations Business Unit QUALITY Location Austria Site Kundl Company / Legal Entity NVS...

  • Senior QA Manager/qp

    vor 5 Monaten


    Kundl, Österreich Sandoz GmbH Vollzeit

    **Senior QA Manager/QP(d/f/m), Sandoz GmbH, Kundl, Austria** Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business...