QA Compliance Expert

Vor 2 Tagen

Stein, Schweiz Novartis Vollzeit

Novartis Technical Operations (NTO) brings billions of units of medicine to countries around the world.

The QA Compliance Expert plans and executes assigned GMP QA Compliance tasks related to the support of sterile manufacturing, such as: supporting qualification/validation activities related to routine manufacturing and launch projects, review and approval of GMP relevant documentation, Change Control, Deviation handling and representation of QA Compliance Qualification & Validation in dedicated project(s).

Your key responsibilities:

- Leading all QA Compliance Qualification & Validation activities within Stein Steriles, PU Galenic (e.g. in project meetings for launch product or meetings related to commercial manufacturing).
- Review and approval of Equipment, Facility and Utilities Qualification Protocols and Re-ports including associated Risk Assessments and Deviations (on paper and/or in COMOS).
- Review and approval of Process Validation Protocols and Reports (Revalidation, Verification, Product Transfers, Computer System Validations and Filter Validations) including associated Risk Assessments and Deviations.
- Review and approval of technical changes (act as QA Gate Approver in Agile PLM ACC) as well as other documents within the scope of the department (e.g. Ongoing Process Verification, Shipping Verifications, Leachable/Extractable reports, etc.).
- Support and perform review and release of manufacturing lines after maintenances (planned and unplanned).
- Perform Quality risk assessments in case of critical/major deviations and initiate management escalation process if applicable.
- Review and approval of SOPs and FRMs within the scope of the department as well as definition and maintenance of relevant procedures.
- Perform & Support of GMP and other relevant trainings within the organization. Onboard/train/develop team members.
- Support inspections and audits (e.g. Health Authority and Customer inspections).

**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**
- Knowledge of current regulations, pharmacopoeia requirements including technical methods (Eudralex, ICH, CFR, USP, Ph. Eur. etc.)
- Excellent communication skills with team members, peers and superiors; Coaches and inspires people to achieve team goals
- Ability to work under time pressure

Desirable requirements:

- (Technical) University or academic degree in Chemistry, Biology, Pharmacy or equivalent OR post graduate diploma in business administration or equivalent
- Spoken and written knowledge of German and English
- Professional experience in Quality Control / Quality Assurance or in the manufacturing of pharmaceutical drug products and Steriles / Biotechnology
- Profound knowledge of cGMPs

You’ll receive:
We offer you a challenging, international and interdisciplinary work environment. Investment in people is a priority for Novartis. We offer a range of possibilities for personal development and career opportunities within the group to motivated, qualified people. We offer you a competitive salary and benefit package. Novartis also supports a flexible work-life integration (working remotely, flexi-time schedules,...). Locally, we offer benefits to ensure our associate's mental and physical well-being. There is a fitness available for our associates to use and we offer a bike-leasing program. We have a mental coach on site as well.

Why consider Novartis?

769 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis

**Division**

Novartis Technical Operations

**Business Unit**

NTO QUALITY

**Country**

Switzerland

**Work Location**

Stein (Säckingen)

**Company/Legal Entity**

Novartis Pharma AG

**Functional Area**

Quality

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

  • QA Compliance Postgraduate

    vor 3 Monaten

    Stein, Schweiz Novartis Vollzeit

    **Summary**: Start date: As soon as possible Duration: 1 year Languages: business-level English and fluent German required **About the Role**: **Your responsibilities will include**: - Ensure all activities are in compliance with cGxP, incl. data integrity - Support with the preparation of Annual Product Quality Review activities according to Novartis...

  • QA Operations Expert

    vor 16 Stunden

    Stein, Schweiz Novartis Vollzeit

    Novartis Technical Operations (NTO) brings billions of units of medicine to countries around the world. Our mission is to ensure the delivery of high quality products to patients around the globe. As a QA Operations Expert you will be responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in...

  • QA Compliance Expert

    vor 1 Tag

    Stein, Schweiz Novartis Vollzeit

    766 million! That's how many patients' lives were touched by our products in 2021. At Novartis, we are reimagining medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many...

  • QA Expert Equipment Qualification and Validation

    vor 7 Monaten

    Stein, Schweiz Lonza Vollzeit

    Switzerland, SteinToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...

  • QA Associate

    vor 7 Monaten

    Stein, Schweiz Datalynx AG Vollzeit

    For our client, a well-known pharmaceutical company in Basel, we are looking for a QA Associate (M/F/d). **Background** Standard activities or routine tasks e.g. batch records reviewer, etc. Supportive project work. Support the timely release of GMP relevant documents and batches. Support departmental projects and objectives according to agreed timelines...

  • Jr. Process Expert Cgt

    vor 7 Monaten

    Stein, Schweiz Novartis Vollzeit

    385593BR **Jr. Process Expert CGT (temp)**: Switzerland **About the role** **Process Expert CGT (temp), Stein, Switzerland** **43 million!** the total no of patients we reached in 2022 through our collective efforts to reimagine medicine and make a real difference to the lives of patients around the world. As a Jr Process Expert you will support PU by...

  • Qm / QA Ims-manager (M/w/d)

    vor 6 Monaten

    Stein, Schweiz G+E GETEC Holding GmbH Vollzeit

    AARGAU (STEIN) - VOLLZEIT - UNBEFRISTET - HSEQ Sie wollen etwas bewirken? Dann sind Sie bei uns genau richtig! Wir suchen Menschen, die unsere Vision teilen und Energie für mehr haben. Unsere Werte spornen uns an: Wir leben Partnerschaft. Wir schaffen Wegweisendes. Wir machen’s einfach! Mit smarten Energie - und Infrastrukturdienstleistungen für...

  • Team Lead QA Ops

    vor 4 Monaten

    Stein, Schweiz Lonza Vollzeit

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • Quality Engineering Specialist

    vor 2 Monaten

    Stein, Schweiz EPM Scientific - Phaidon International Vollzeit

    We are seeking a QA Specialist, CSV & Automation.The ideal candidate will be responsible for overseeing the qualification and validation compliance of equipment and computerized systems related to aseptic facilities, utilities, and GMP manufacturing as part of Lonza's CAPEX project portfolio in Stein, AG.Key Responsibilities:Oversee the qualification and...

  • Quality Assurance Manager Pharma

    Vor 2 Tagen

    Stein, Schweiz Universal-Job Vollzeit

    In this position you are responsible for the following tasks: - Ensure compliance according to internal quality standards, relevant regulatory requirements and the filed product quality standards - Ensure QA monitoring of the allocated products in the QC organization - Manage all quality aspects of a portfolio of products in terms of re-lease, validation,...

  • Process Expert

    Vor 6 Tagen

    Stein, Schweiz Novartis Vollzeit

    Over 799 million! - that's how many lives we reached with our products in 2021. And while we are proud of this, we continuously ask ourselves the question: how can we improve and extend even more lives in a world of digital and technological change? We are convinced that we can find answers if curious, courageous and team-oriented people are encouraged to...

  • Process Expert

    vor 4 Monaten

    Stein, Schweiz Novartis Vollzeit

    **Summary**: A new and exciting opportunity has presented itself in CGT Stein. Join our team as a Process Expert, where you will providing front line technical and scientific expert support for all process-specific issues to ensure execution of processes on-time (business continuity); in compliance to cGMPs, SOPs and applicable guidelines and functional...

  • QA Manager

    vor 7 Monaten

    Stein, Schweiz Lonza Vollzeit

    Switzerland, SteinToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...

  • Internationales Logistikmanagement-Experte für den perfekten internationalen Versand

    Vor 5 Tagen

    Stein, Aargau, Schweiz SKAN AG Vollzeit

    JobbeschreibungAufgabenbereich: Unser Team ist Teil der internationalen Logistik von SKAN AG, einer führenden Schweizer Firma im Bereich des Import- und Exportgeschäfts. Wir sind auf der Suche nach einem erfahrenen Logistikmanager, der sich mit Erfolg in der Position eines Internationalen Logistikmanagers beweisen kann.Zielsetzung: Als Internationales...

  • Process Expert Drug Product

    Vor 3 Tagen

    Stein, Schweiz Lonza Vollzeit

    Switzerland, SteinToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...

  • CSV Engineer

    vor 1 Monat

    Stein SG, Schweiz Randstad (Schweiz) AG Vollzeit

    JobdescriptionCSV Engineer (m/f/d)Location: Stein, SwitzerlandCompany: LonzaEmployment Type: Full-TimeJoin Lonza, a global leader in life sciences, and contribute to impactful pharmaceutical projects. We are seeking a CSV Engineer to support the commissioning, qualification, and validation (CQV) activities of cutting-edge systems in Stein,...

  • Cleaning Validation Expert

    vor 6 Monaten

    Stein, Schweiz Lonza Vollzeit

    Switzerland, SteinCleaning Validation Expert Location - Stein, Switzerland Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In...

  • Head Manufacturing Compounding and Support Dps

    Vor 3 Tagen

    Stein, Schweiz Lonza Vollzeit

    Switzerland, SteinToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...

  • Lead Training

    Vor 3 Tagen

    Stein, Schweiz Lonza Vollzeit

    Switzerland, SteinToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...

  • Logistik-Experte mit Erfahrung im Pharmabereich gesucht

    Vor 6 Tagen

    Stein, Aargau, Schweiz Gi Group SA Vollzeit

    Wir suchen bei Gi Group SA nach einer motivierten Persönlichkeit für die Funktion als Lagerlogistikexperte. Das Leistungsmodul Logistics Solutions Basel & Kaiseraugst bietet geschäftliche Serviceleistungen und stellt qualitativ hochwertige, kosteneffiziente Angebote zur Verfügung. Der einfache und unkomplizierte Zugang zu den verschiedenen Services ist...