QA Operations Specialist

Vor 6 Tagen

Bezirk Stein SH, Schweiz Lonza AG Vollzeit

Switzerland, Stein

QA Operations Specialist 80-100% (m/f/d)

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 exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The primary purpose of the role is to ensure a Right Time in Inspection Readiness for a Big CAPEX project (encompassing a Fill Finish Facility, Laboratories, Warehousing, Shipment and Offices). The role will manage QA operational activities to support departmental projects and objectives according to agreed timelines and standards and ensure compliance with GMP is maintained in Sterile Production Plant Stein. Then, after the project phase, will manage the quality activities as operational QA (e.g. Batch Release, deviation, etc.)

Key Responsibilities:

  • Write, review and/or approve deliverables (e.g. procedures, SOPs, cleaning documents, batch documentation, gap assessments, change request, deviation and CAPA) and related data bases (e.g. training, validation) to ensure GMP compliance.
  • Support project and maintain Sterile Production Stein line functions in GMP compliance related issues.
  • Promote and enforce compliance to internal and external guidelines regarding quality and safety.
  • Lead development and evaluation of new tools, processes, quality initiatives & plans, actively participate in continuous improvement.
  • Represent Sterile Production Stein QA in inspections, audits and local and global initiatives.
  • Ensure internal and customer support in regards to global initiatives (e.g. quality alerts)

Key requirements:

  • University or academic degree (e.g. Master) in Chemistry, Biology, Pharmacy or equivalent
  • Professional experience in Quality Assurance or Quality Control in a manufacturing environment within Pharmaceutical Industry > 7 years
  • Excellent knowledge of cGMP regulations
  • Sound knowledge in manufacturing of chemical and biological drug products
  • Problem solving skills
  • Sets clear priorities for task for him
  • Customer oriented and collaboration with Process Unit team
  • Ensuring cGMP and regulatory compliance of all relevant operations in the Process Unit
  • Excellent English skills (spoken and written) German is an advantage

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

#LI-SG1

Reference: R59178Apply Switzerland, Stein

  • QA Operations Expert

    vor 2 Wochen

    Stein, Schweiz Novartis Vollzeit

    Novartis Technical Operations (NTO) brings billions ofunits 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...

  • Cell Processing Specialist

    Vor 6 Tagen

    Bezirk Stein SH, Schweiz Novartis Pharma AG Vollzeit

    Job ID REQ-10009030 Jun 06, 2024 Switzerland Summary 10 ! days - that is how long we in Cell & Gene Therapy treat a patient’s T-cells, before returning them with the potential to save a patient’s life. This is a unique and novel personalized treatment where we work with the patient’s own cells during our production process. Not only are re imagining...

  • QA Expert Equipment Qualification and Validation

    vor 3 Wochen

    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...

  • QC Analyst I

    Vor 6 Tagen

    Bezirk Stein SH, Schweiz Novartis Pharma AG Vollzeit

    Job ID REQ-10008655 Jun 18, 2024 Switzerland Summary ~Unterstützt alle Aktivitäten innerhalb der zugewiesenen Qualitätsabteilung. Trägt zur Implementierung, Wartung und Ausführung der zugewiesenen Qualitäts- und / oder Laborsysteme auf effektive und konforme Weise bei. About the Role Deine Hauptaetigkeiten: ~ Liefert technischen und/oder...

  • Operational Scheduler, Cgt

    vor 3 Wochen

    Stein, Schweiz Novartis Vollzeit

    As an Operational Scheduler/ Production Planner Associate you will be working under limited supervision, will be responsible for developing and manage the execution of the supply plan based on agreed upon safety stock levels while optimizing commercial and clinical production operations, including PU personnel planning. Major Accountabilities: - Execution...

  • QC Analyst I

    Vor 6 Tagen

    Stein, Aargau, Schweiz Novartis AG Vollzeit

    Job ID REQ Jun 18, 2024 Switzerland Summary~Unterstützt alle Aktivitäten innerhalb der zugewiesenen Qualitätsabteilung. Trägt zur Implementierung, Wartung und Ausführung der zugewiesenen Qualitäts- und / oder Laborsysteme auf effektive und konforme Weise bei.About the RoleDeine Hauptaetigkeiten:~ Liefert technischen und/oder administrativen Spport für...

  • Jr. Process Expert Cgt

    vor 3 Wochen

    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...

  • Process Expert Drug Product 80

    vor 3 Wochen

    Stein, Schweiz Lonza Vollzeit

    Switzerland, SteinLonza ist heute ein weltweit führendes Unternehmen im Bereich Life Sciences, welches auf drei Kontinenten tätig ist. Wir sind in der Wissenschaft tätig, jedoch gibt es keine Zauberformel dafür, wie wir die Arbeit angehen. Unsere wichtigste wissenschaftliche Lösung sind talentierte Mitarbeitende, die zusammenarbeiten und Ideen...

  • Process Expert Drug Product 80

    Vor 5 Tagen

    Stein, Schweiz Lonza Vollzeit

    Switzerland, SteinLonza ist heute ein weltweit führendes Unternehmen im Bereich Life Sciences, welches auf drei Kontinenten tätig ist. Wir sind in der Wissenschaft tätig, jedoch gibt es keine Zauberformel dafür, wie wir die Arbeit angehen. Unsere wichtigste wissenschaftliche Lösung sind talentierte Mitarbeitende, die zusammenarbeiten und Ideen...

  • Process Expert Drug Product 80

    vor 2 Wochen

    Stein, Schweiz Lonza Vollzeit

    Switzerland, SteinLonza ist heute ein weltweit führendes Unternehmen im Bereich Life Sciences, welches auf drei Kontinenten tätig ist. Wir sind in der Wissenschaft tätig, jedoch gibt es keine Zauberformel dafür, wie wir die Arbeit angehen. Unsere wichtigste wissenschaftliche Lösung sind talentierte Mitarbeitende, die zusammenarbeiten und Ideen...

  • Production Operator

    vor 2 Wochen

    Stein, Schweiz Edp Personalberatung Gmbh Vollzeit

    Cell Processing Specialist - Exciting Opportunity! Responsible for Day 0 operations, cell washing, Harvest processing, and verifying cell processing associates Formulation and verification of all media lots This role requires a high level of proficiency and ownership due to the nature of patient-derived starting material. Key Responsibilities: ...

  • Senior Technical Project Manager

    vor 2 Monaten

    Remote, SH, Schweiz TE Connectivity Solutions GmbH Vollzeit

    Senior Technical Project ManagerAt TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.  Job Overview TE Connectivity's Business Development Teams identify, develop, and implement near-term and long-term business development strategies relating to the...

  • Technical Project Manager

    vor 4 Wochen

    Remote, SH, Schweiz TE Connectivity Solutions GmbH Vollzeit

    Technical Project ManagerAt TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job OverviewTE Connectivity's Business Development Teams identify, develop, and implement near-term and long-term business development strategies relating to the development of...

  • Senior Technical Project Manager

    vor 4 Wochen

    Remote, SH, Schweiz TE Connectivity Solutions GmbH Vollzeit

    Senior Technical Project ManagerAt TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job OverviewTE Connectivity's Business Development Teams identify, develop, and implement near-term and long-term business development strategies relating to the...

  • Technical Project Manager

    vor 2 Monaten

    Remote, SH, Schweiz TE Connectivity Solutions GmbH Vollzeit

    Technical Project ManagerAt TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job OverviewTE Connectivity's Business Development Teams identify, develop, and implement near-term and long-term business development strategies relating to the development of...

  • Senior Technical Project Manager

    vor 2 Monaten

    Remote, SH, Schweiz TE Connectivity Solutions GmbH Vollzeit

    Senior Technical Project ManagerAt TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job OverviewTE Connectivity's Business Development Teams identify, develop, and implement near-term and long-term business development strategies relating to the...

  • SAP Consultant SD/LE

    vor 1 Monat

    Beringen SH, Schaffhausen, Schweiz Syntegon Technology Services AG Vollzeit

    Join us on this new adventure. Are you ready?Syntegon Technology is a leading global provider of process and packaging technology. With approximately 6,000 colleagues in over 15 countries, the Syntegon Group is dedicated to developing intelligent and sustainable solutions for the pharmaceutical and food industries.Syntegon Technology Services AG in Beringen...

  • SAP Consultant SD/LE

    vor 4 Wochen

    Beringen SH, Schaffhausen, Schweiz Syntegon Technology Services AG Vollzeit

    Join us on this new adventure. Are you ready?Syntegon Technology is a leading global provider of process and packaging technology. With approximately 6,000 colleagues in over 15 countries, the Syntegon Group is dedicated to developing intelligent and sustainable solutions for the pharmaceutical and food industries.Syntegon Technology Services AG in Beringen...

  • Senior Technical Project Manager

    vor 4 Wochen

    Remote, SH, Schweiz TE Connectivity Solutions GmbH Vollzeit

    Senior Technical Project ManagerAt TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.  Job Overview TE Connectivity's Business Development Teams identify, develop, and implement near-term and long-term business development strategies relating to the...

  • Senior Technical Project Manager

    vor 2 Wochen

    Remote, SH, Schweiz TE Connectivity Solutions GmbH Vollzeit

    Senior Technical Project ManagerAt TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job OverviewTE Connectivity's Business Development Teams identify, develop, and implement near-term and long-term business development strategies relating to the...