QA Manager 80-100%
vor 18 Stunden
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 and small, genuinely improve the world. And that’s the kind of work we want to be part of.
In order to support the strategic investments of the company in Stein (Switzerland) Quality SGIE (Strategic Growth Investments & Engineering) is looking for an experienced Quality Assurance Manager (f/m/d) responsible for the Commissioning & Qualification (C&Q) compliance of an aseptic fill-finish drug product manufacturing facility CAPEX project.
Key responsibilities:
- Responsible for the quality oversight and regulatory aspects of the assigned CAPEX project
- Ensuring C&Q compliance of GMP systems related to the aseptic fill-finish facility (equipment/utilities/facilities) during the project management lifecycle from design engineering through to the initial C&Q and handover phases
- Reviewing and approving C&Q documents of GMP systems as well as related changes and deviations
- Supporting audits and regulatory inspections (Swissmedic, FDA, etc.)
- Providing leadership and guidance to project team members on C&Q strategy and issues
- Ensuring that decisions are fully supported by global and local Quality, as well as Regulatory
- Escalating issues in an open and timely manner and take leadership for their resolution
Key requirements:
- Academical degree (minimum Bachelor) in Engineering, Life Sciences or related field, or equivalent work experience
- Significant experience in the GMP regulated pharmaceutical industry, preferably in a role within a Quality Unit
- Experience in a QA role for the C&Q of GMP systems related to aseptic fill-finish processes and facility (filling equipment, lyophilization, clean utilities, and clean room facilities)
- Fluent in English, German would be 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.
**Reference: R54157**:
- Apply
-
Qm / QA Ims-manager (M/w/d)
vor 7 Monaten
Stein, Schweiz G+E GETEC Holding GmbH VollzeitAARGAU (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...
-
Senior QA Expert Manufacturing Release 80-100%
Vor 6 Tagen
Stein (AR), Schweiz Lonza Group Ltd. VollzeitSenior QA Expert Manufacturing Release 80-100% (m/f/d) page is loaded Senior QA Expert Manufacturing Release 80-100% (m/f/d) Apply locations CH - Stein time type Full time posted on Posted 20 Days Ago job requisition id R59178 Today, Lonza is a global leader in life sciences operating across three continents. While we work...
-
Team Lead QA Ops 80-100%
Vor 5 Tagen
Stein (AR), Schweiz Lonza Group Ltd. VollzeitTeam Lead QA Ops 80-100% (m/f/d)Apply locations CH - Stein time type Full time posted on Posted 2 Days Ago job requisition id R62496Today, 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,...
-
QA Expert Equipment Qualification and Validation
vor 7 Monaten
Stein, Schweiz Lonza VollzeitSwitzerland, 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...
-
Senior QA Expert for QC 80
Vor 2 Tagen
Stein (AR), Schweiz Lonza Group Ltd. VollzeitSenior QA Expert for QC 80 - 100% (m/f/d)Apply locations CH - Stein time type Full time posted on Posted 2 Days Ago job requisition id R59092Today, 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...
-
QA Associate Manufacturing Release 80-100%
Vor 3 Tagen
Stein, Schweiz Lonza VollzeitSwitzerland, 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 Teamlead Qualification and Validation 80-100%
Vor 7 Tagen
Stein, Schweiz Lonza VollzeitSwitzerland, 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...
-
Team Lead QA Ops 80-100%
Vor 2 Tagen
Stein (AR), Schweiz Lonza Biologics Porriño SLU 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 QA Expert for QC 80
Vor 6 Tagen
Stein, 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,...
-
QA Operations Expert
Vor 7 Tagen
Stein, Schweiz Novartis Vollzeit300 Million. This is the number of people suffering from autoimmune diseases worldwide. Join our team as QA Compliance Manufacturing Manager (f/m) in our most advanced biopharmaceutical production and help to improve their lives. A QA Operations Expert performs a compliant and timely release of dosage forms according to applicable local and international...
-
Quality Assurance Manager Pharma
vor 2 Wochen
Stein, Schweiz Universal-Job VollzeitIn 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,...
-
Senior QA Expert Manufacturing Release 80-100%
Vor 6 Tagen
Stein, 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,...
-
QA Manager
vor 7 Monaten
Stein, Schweiz Lonza VollzeitSwitzerland, 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 VollzeitFor 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...
-
Team Lead QA Ops
vor 4 Monaten
Stein, 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,...
-
Logistiker 80-100% (M/F/d)
Vor 3 Tagen
Stein, Schweiz Lonza VollzeitSwitzerland, 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...
-
QA Manager Qualification
vor 2 Wochen
Stein, Schweiz Lonza VollzeitSwitzerland, 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 Compliance Expert
vor 1 Woche
Stein, Schweiz Novartis Vollzeit766 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 Manager
vor 18 Stunden
Stein, Schweiz Lonza VollzeitSwitzerland, 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...
-
Quality Engineering Specialist
vor 3 Monaten
Stein, Schweiz EPM Scientific - Phaidon International VollzeitWe 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...