Team Lead QA Ops 80-100%
vor 4 Stunden
Apply locations CH - Stein time type Full time posted on Posted 2 Days Ago job requisition id R62496
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.
Located in Stein our successful CDMO Business Unit Drug Product Services (DPS) offers exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as Team Lead QA Operations, Growth Project 80 – 100% supporting our new sterile Drug Product facility.
Key responsibilities:
- Execute establishment and maintenance of the Quality Oversight at DPS Manufacturing (aseptic manufacturing, process simulations (APS), environmental sampling, proper qualification of DPS staff in aseptic techniques)
- Lead and manage a team of at least 8 quality operations experts and develop them
- Review and approve protocols and reports for e.g. APS, holding time studies, cleaning studies, equipment/room qualification as applicable including documents in electronic systems (e.g. batch records, SOPs)
- Document Authoring, Review and approval including documents (e.g. batch records, SOPs)
- Supervise and execute GMP compliance activities like changes, non-conformities, document management, e.g. last approver of major deviations for manufacturing incl. executing the deviation review board and open requests to re-open TrackWise records via the TW support team
- Provide practical and theoretical trainings for e.g. Trackwise changes, personnel qualification
- Guide team members in line with Lonza values and behaviors including objective setting performance evaluations, development planning and participate in the recruiting process
- Support a culture of high performance and trust. Assure that the required level of knowledge and skills is available and identify competency gaps
- Establish and implement training and development plans
- Ensure effective use of resources (budget, time, personnel, systems)
- Counsel and support Sterile Production line functions, customers and groups in DPS like manufacturing, formulation and process development, business development in GMP compliance related issues in area of expertise
- Write/Contribute to internal compliance policy and/or comment to regulations
- Management and reporting of KPIs
- Represent QA Operations in inspections, audits and local and global initiatives
- Perform/support self-inspections and audits as required
- Enforce adherence to GMP for sterile manufacturing/aseptic filling (acts as first contact concerning compliance issues / quality alerts for local and shared systems)
- Perform other duties as assigned
- Deputy of Head of QA Operations-Growth Project as required
Key requirements:
- University or academic degree (e.g. Masters) in Chemistry, Biology, Pharmacy or equivalent
- 10-15 years of professional experience in Quality Assurance and/or Quality Control in a manufacturing environment within the pharmaceutical Industry, preferably in Sterile manufacturing of drug products
- Proven record of 2-4 years of people management, of more than 6-8 direct reports
- Possess in-depth knowledge of Good Manufacturing Practice (GMP); sterile drug product aseptic manufacturing, Annex I regulations and ICH guidelines
- Experience in Swissmedic inspections, FDA inspections, and other health authorities is desired
- Exceptional leadership and people management skills. Interpersonal savvy – capable of managing multiple points of view and building partnerships
- Excellent communication, presentation and listening skills are a must for this role
- Ability to handle ambiguity and complexity of Growth Projects is a plus
- Relate to others in a team setting. Active listener seeking to understand and to be understood. Able to coach and manage experienced and inexperienced staff
- Fluency in English (spoken and written) is a must. At least B1 Level (spoken and written) in German is required
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-
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
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,...
-
Postgraduate QA Operations
Vor 4 Tagen
Stein, Schweiz Novartis Vollzeit60 million! This number of pre-filled syringes, vials and ampoules are manufactured each year at the Stein Steriles facility and shipped as medicines to more than 150 countries. Become part of a demanding, dynamic and quality-oriented team and support us in the quality of innovative, biotechnological products in one of the most important Novartis production...
-
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,...
-
(Senior) QA Expert Compliance
vor 4 Stunden
Stein (AR), Schweiz Lonza Group Ltd. Vollzeit(Senior) QA Expert Compliance (f/m/d)Apply locations CH - Stein time type Full time posted on Posted 4 Days Ago job requisition id R64563Today, 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 Teamlead Qualification and Validation 80-100%
Vor 2 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...
-
Senior QA Expert for QC 80
vor 1 Tag
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 Compliance Postgraduate
vor 3 Monaten
Stein, Schweiz Novartis Vollzeit**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...
-
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...
-
QA Compliance Expert
Vor 6 Tagen
Stein, Schweiz Novartis VollzeitNovartis 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...
-
Stein (AR), Schweiz Lonza Group Ltd. Vollzeit(Senior) Quality Assurance Expert for pharmaceutical QMS and combination products 80-100% (m/f/d)Apply locations CH - Stein CH - Basel time type Full time posted on Posted 2 Days Ago job requisition id R61580Today, 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...
-
QA Operations Expert
Vor 5 Tagen
Stein, Schweiz Novartis VollzeitNovartis 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...
-
Lead Training
vor 1 Woche
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...
-
Qm / QA Ims-manager (M/w/d)
vor 6 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...
-
QA Operations Expert
Vor 2 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...
-
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...
-
QA Manager Qualification
vor 1 Woche
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 Critical Utilities Lead
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...
-
Automation Lead
vor 1 Monat
Stein (AR), Schweiz Lonza Group Ltd. 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,...
-
Automation Lead
vor 4 Wochen
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,...
