QA Expert Equipment Qualification and Validation

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...

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...

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...

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...

We are seeking a skilled C&Q Specialist to lead commissioning and qualification activities for QC laboratory systems, equipment, and support utilities. This role ensures compliance with GMP standards and regulatory requirements while supporting cross-functional teams and external vendors.Key Responsibilities:Act as SME for QC laboratory C&Q scope.Plan,...

**Summary**: As a Validation Expert you will be executing process, primary packaging, and cleaning validation activities and change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory expectations. **About the Role**: **Key Responsibilities**: - Support Product...

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,...

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...

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...

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...

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,...

**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...

**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...

Job description: - The scope of activities includes the coordination on the installation of equipment, HVAC & Utilities (20%) - Drafting the IQ/OQ/PQ protocols, execution of the IQ/OQ/PQ and documenting the results according cGMP requirements. - Validation activities including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution,...

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...

**Key Responsibilities**: - Lead and execute CQV activities for Fill Finish equipment and processes. - Develop and review validation protocols (IQ, OQ, PQ) and reports. - Coordinate with cross-functional teams to ensure timely completion of CQV deliverables. - Troubleshoot and resolve technical issues related to Fill Finish processes. - Ensure adherence to...

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...

Responsibilities:Acting as subject matter expert (SME) on following Lonza CQV / CSV standardsCSV person of contact of the assigned system till the handover to the operation organizationParticipate to the system impact assessment as CSV SMEDefine with EMR and Package Units vendor the most appropriate design for vertical integration in the Lonza...

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,...

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...