QA Csv&equipment Qualification Qc
vor 2 Wochen
**QA CSV & Qualification for L**aboratory Equipment**:
**Switzerland, **Visp**
**Job Description Summary**
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.
Equipment used for the analysis of chemical and biological products has to be properly tested and is released/approved by authorized people for its intended use. The increasing computerization of laboratory equipment adds complexity. The corresponding systems require a computerized system validation to cover risks as data integrity or ensuring the correct equipment/software parameters.
The QA Specialist CSV & Qualification (M/F/d) will be part of a team that is currently established to release laboratory equipment for QC activities.
He/She represents the Quality Assurance Unit, releases Deviations that arise during qualification or the life cycle of the equipment, helps to assess the impact on products and helps to define appropriate CAPA(s) as solutions.
**Key **respons**i**bilities**:
- Controls, approves/releases computerized system validation documents by following regulatory guidelines and local operating procedures
- Controls, approves/releases qualification documents by following regulatory guidelines and local operating procedures
- Approves/releases equipment related Deviations
- Ensures cGMP compliance
- Supports the business through ongoing change and process improvement activities.
**Key **requirements**:
- Bachelor or Master degree in IT, chemistry, biotechnology, life science or related field.
- Previous experience in Deviations and cGMP in a regulated pharmaceutical/API industry is a strong advantage.
- Knowledge of biotech. manufacturing processes and analytical methods is an advantage.
- Experience with Human and Organizational Performance & risk management approaches is an advantage
- Fluency in German, both written and spoken. English is an advantage.
- Technical writing & presentation/communication skills are key for the role. Demonstrated previous experience is a strong advantage.
- Structured, focused and well-organised working attitude. Open-minded for new ideas and suggestions; agile, highly motivated and dynamically driven.
- Ability to work with and lead a team of SMEs without formal authority, as well as to deliver projects working independently.
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.
-
QA for QC Expert
vor 1 Monat
Visp, Schweiz wega Informatik AG VollzeitOn behalf of our customer in the life sciences field, we are seeking a QA for QC Expert who will play a fundamental role in ensuring highest quality standards of their products. Start date: asap Duration: 1 year (extension possible) Workload: 80 - 100% Location: Visp (3 days onsite) Your Area of Responsibilities: Supporting the QC department in the...
-
Senior QA Specialist Qualification
vor 4 Monaten
Visp, Schweiz Lonza VollzeitToday, 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,...
-
Qc Expert
vor 2 Monaten
Visp, Schweiz wega Informatik VollzeitOn behalf of our customer in the life sciences field, we are seeking a QC Expert who will play a fundamental role in ensuring highest quality standards of their products. Start date: asap Duration: 1 year (extension possible) Workload: 80 - 100% Location: Visp (3 days onsite) **Your Area of Responsibilities**: - Supporting the QC department in the...
-
Senior CSV Systems Engineer
vor 2 Wochen
Visp, Schweiz Lonza VollzeitJob Description:At Lonza, we rely on talented individuals to drive our scientific solutions forward. We're currently seeking a highly skilled Senior CSV Systems Engineer to join our team.About the Role:As a Senior CSV Systems Engineer, you will be responsible for generating and executing the validation of computerized systems on process engineering equipment...
-
QA for Qc Manager
vor 6 Monaten
Visp, Schweiz Lonza VollzeitSwitzerland, VispQA for QC Manager 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...
-
CSV Specialist for Biologics Validation
vor 3 Wochen
Visp, Schweiz Lonza VollzeitRole OverviewWe are seeking a highly skilled CSV Specialist for Biologics Validation to join our team at Lonza. As a CSV Specialist, you will play a critical role in ensuring the validity and reliability of our computerized systems.Key ResponsibilitiesDevelop and execute validation plans for computerized systems on process engineering equipment and...
-
Senior CSV Validation Engineer
vor 1 Monat
Visp, Schweiz Lonza VollzeitAt Lonza, we're committed to excellence in life sciences. As a Senior CSV Validation Engineer, you'll play a critical role in ensuring the integrity of our computerized systems. Your expertise will be instrumental in validating and executing CSV activities, ensuring compliance with regulatory requirements.Key responsibilities:Develop and execute CSV plans...
-
Biologics CSV Validation Expert
vor 1 Woche
Visp, Schweiz Lonza Vollzeit**About Us**Lonza is a global leader in life sciences with operations across three continents. Our company's success stems from talented individuals working together to devise innovative solutions that help businesses improve people's lives.We offer our employees the autonomy to own their careers, and we encourage them to contribute their ideas, no matter...
-
Biologics CSV Specialist
vor 4 Wochen
Visp, Schweiz Lonza VollzeitAt Lonza, we're driven by a passion for life sciences and a commitment to excellence. As a Biologics CSV Specialist, you'll play a critical role in ensuring the integrity of our computerized systems, ensuring they meet the highest standards of quality and compliance.Key Responsibilities:Develop and execute commissioning and validation plans for new systems,...
-
Biologics CSV Validation Specialist
vor 4 Wochen
Visp, Schweiz Lonza VollzeitAt Lonza, we're driven by a passion for life sciences and a commitment to excellence. As a Biologics CSV Validation Specialist, you'll play a critical role in ensuring the integrity of our computerized systems, from planning and implementation to ongoing optimization.Key Responsibilities:Develop and execute commissioning and validation plans for new systems,...
-
Senior QA Specialist
vor 5 Monaten
Visp, Schweiz Lonza VollzeitToday, 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,...
-
Qc Laboratory Technician Microbiology
vor 5 Monaten
Visp, Schweiz Bacthera VollzeitBacthera is a leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. We operate from our headquarters in Basel (CH) and have production facilities in Denmark and Switzerland. We bring together best-in-class, complementary capabilities and we are...
-
Qc Laboratory Technician Physico-chemical
vor 6 Monaten
Visp, Schweiz Bacthera VollzeitBacthera is a leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. We operate from our headquarters in Basel (CH) and have production facilities in Denmark and Switzerland. We bring together best-in-class, complementary capabilities and we are...
-
QA Analytics Specialist
vor 2 Wochen
Visp, Schweiz Lonza VollzeitQA Analytics Specialist (Hybrid) Location: VISP Hybrid Working Model (3 days in the office, 2 days WFH) 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...
-
QA Analytics Specialist
vor 3 Monaten
Visp, Schweiz Lonza VollzeitQA Analytics Specialist (Hybrid) Location: VISP Hybrid Working Model (3 days in the office, 2 days WFH) 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...
-
CSV Engineer
vor 3 Wochen
Visp, Schweiz Lonza VollzeitToday, 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,...
-
CSV Engineer Biologics
vor 6 Monaten
Visp, Schweiz Lonza VollzeitToday, 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,...
-
Senior CSV Engineer
vor 1 Woche
Visp, Schweiz Lonza VollzeitToday, 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,...
-
Senior CSV Engineer
vor 1 Woche
Visp, Schweiz Lonza Group Ltd. VollzeitSenior CSV Engineer - Biologics (m/f/d)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...
-
Senior CSV Engineer
vor 6 Monaten
Visp, Schweiz Lonza VollzeitToday, 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,...
