QA Analytics Specialist
vor 2 Monaten
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 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 role:
The QA (Quality Assurance) Analytics Team is recruiting a dedicated person who wants to work as a Senior QA Specialist in analytics in a fast-growing and innovative environment. As a Senior QA Specialist for Analytics, you will be responsible for ensuring Quality oversight on GMP-relevant activities carried out by the Quality Control and Analytical Development (AD) departments.
This includes the review and approval of SOPs, analytical methods/specifications, and validation plans/reports assuring their compliance with Lonza’s standards, customer requirements, and health authority expectations. Moreover, as a Quality and Compliance representative, you are a key member of cross-functional project teams, e.g. for process transfers and new product introductions.
Key responsibilities:
- Representing the QA concerns to the Quality Control (QC) department and ensuring that cGMP requirements and SOPs are followed.
- Control and release of GMP relevant documents of the QC, including review and approval of SOPs, analytical test methods, method transfer protocols/reports, and method validation protocols/reports.
- QA supervision for OOX events during investigation in QC/AD: Review and approve Out-of-Specifications/-Expectations/-Trend results.
- Write or revise SOPs in the area of expertise and ownership of these documents.
- Ensuring compliance with cGMP in the areas of stability testing and reference standards.
- Cooperation, review, and approval of deviations (DRs), Investigations (INV), changes (CRs), and CAPAs within analytics (QC).
- Participating in customer Audits and Inspections.
Key requirements:
- Bachelor's or master's degree in chemistry, biotechnology, life science, or related field.
- Significant experience in the pharmaceutical industry; preferably in a QC or QA function.
- Founded analytical expertise and experience with analytical method validation.
- Strong background in cGMP regulations; incl. USP, European and Japanese Pharmacopoeia.
- Auditing experience and experience in the interaction with health authorities (FDA, Swissmedic, etc.).
- Excellent verbal and written communication in English. German language knowledge is advantageous.
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.
#J-18808-Ljbffr-
QA Analytics Raw Data Reviewer
Vor 5 Tagen
Visp, Schweiz Lonza Group Ltd. VollzeitQA Analytics Raw Data Reviewer page is loadedQA Analytics Raw Data ReviewerApply locations CH - Visp time type Full time posted on Posted 4 Days Ago job requisition id R64235QA Analytics Raw Data ReviewerSwitzerland, VispToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to...
-
QA Analytics Raw Data Reviewer
Vor 5 Tagen
Visp, Schweiz Lonza VollzeitQA Analytics Raw Data ReviewerSwitzerland, VispToday, 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...
-
QA Analytics Raw Data Reviewer
vor 1 Monat
Visp, Schweiz Lonza Vollzeit**QA Analytics Raw Data Reviewer**: Switzerland, Visp 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...
-
QA Reviewer
vor 7 Monaten
Visp, Schweiz Panda International Vollzeit**QA Reviewer**: **Location** - Visp, Switzerland **Business Sector** - Biotechnology **Contact name** - Aliyana Darwesh **Job ref** - 22218 **Published** - 8 days ago **QA Reviewers - Urgent Remediation Project** Currently working with a scale-up Biotech Client in need of support from QA Reviewers for high-level projects in Switzerland. This is an...
-
QA Validation Specialist PQR
Vor 5 Tagen
Visp, Schweiz EPM Scientific - Phaidon International VollzeitWe are seeking a QA Validation Specialist with expertise in Product Quality Review (PQR) to join our Client team in Visp on a one-year contract. In this role, you will:Ensure the trainings required for the Process Validation Specialist with focus on Product Quality Review are completed.Actively participate and contribute to the validation team.Support the...
-
QA Specialist Batch Record Review
vor 4 Wochen
Visp, Schweiz Lonza Group Ltd. VollzeitQA Specialist Batch Record ReviewApply locations CH - VispTime type: Full timePosted on: Posted 2 Days AgoJob requisition id: R64143For IBEX Solutions (www.ibex.lonza.com), our recently launched unique biological manufacturing and development concept in Visp, Switzerland, we have multiple openings. Become part of this exciting opportunity and join our team...
-
QA Validation Specialist PQR
Vor 4 Tagen
Visp, Schweiz Panda International VollzeitTogether with EU's largest CDMO, we are seeking a dedicated and detail-oriented QA Validation Specialist to join their team in Switzerland with a focus on Product Quality Review (PQR). The professional will play a pivotal role in ensuring compliance with quality standards and regulatory requirements while contributing to the continuous improvement of...
-
Senior QA Specialist
vor 4 Wochen
Visp, Schweiz Lonza Group Ltd. VollzeitSenior QA Specialist - Project Manager (f/m/d)Location: CH - VispTime Type: Full timePosted On: Posted 2 Days AgoJob Requisition ID: R64351Today, Lonza is a global leader in life sciences operating across three continents. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we...
-
QA Project Manager
vor 7 Monaten
Visp, Schweiz Lonza VollzeitSwitzerland, VispToday, 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 QA Specialist
vor 2 Monaten
Visp, Schweiz Lonza VollzeitLead QA Specialist – Infrastructure and LogisticsLocation: VISPHybrid 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...
-
Senior QA Specialist
vor 3 Wochen
Visp, Schweiz Lonza VollzeitSenior QA Specialist - Project Manager (f/m/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...
-
Small Equipment Specialist
vor 2 Monaten
Visp, Schweiz Lonza Group Ltd. VollzeitSmall Equipment Specialist Lonza 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 Csv&equipment Qualification Qc
vor 2 Monaten
Visp, Schweiz Lonza Vollzeit**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...
-
Chemie- Und Pharmatechnologe in Prozessanalytik
Vor 4 Tagen
Visp, Schweiz Lonza VollzeitSwitzerland, VispLonza 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 Associate Director
vor 7 Monaten
Visp, Schweiz Lonza VollzeitSwitzerland, VispToday, 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...
-
Small Equipment Specialist
vor 3 Wochen
Visp, Schweiz Lonza VollzeitToday, Lonza is a global leader in life sciences operating across five 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,...
-
Small Equipment Specialist
vor 1 Monat
Visp, Schweiz Lonza VollzeitSwitzerland, Visp Today, Lonza is a global leader in life sciences operating across five 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...
-
Application Specialist
vor 3 Wochen
Visp, Schweiz Hays (Schweiz) AG VollzeitFreelance/temporary employment for a projectVisp, ValaisStart date: asapReference number: 794022/1ResponsibilitiesSystem Administration; manage and maintain system access. Develop processes to monitor and maintain systemSupport project teams in set up of projects and user accessSupports with troubleshooting and resolution of issuesSolicits feedback from end...
-
Application Specialist
vor 2 Monaten
Visp, Schweiz Hays VollzeitResponsibilities:System Administration; manage and maintain system access. Develop processes to monitor and maintain system.Support project teams in the setup of projects and user access.Support troubleshooting and resolution of issues.Solicit feedback from end users to understand needs, application use, and potential improvements. Provide training,...
-
Teamlead Innovation& Routine
vor 3 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,...
