Area Quality Owner
vor 4 Wochen
Cilag AG in Schaffhausen, Switzerland, is part of the Johnson & Johnson Innovative Medicine (J&J IM) organization, and is currently recruiting for an
Area Quality Owner (AQO) Parenterals
We manufacture high quality pharmaceutical products and active pharmaceutical ingredients (APIs). Today Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all the major global markets. The Schaffhausen facility is a Johnson & Johnson strategic launch and growth site for parenteral products, and we have an impressive pipeline of new and innovative products
Position summary
As an AQO in QA Process Parenterals you will join a dynamic team which is responsible for Quality and Compliance guidance, as well as Quality and Aseptic oversight of equipment and premises used for manufacturing in the Business Units Parenterals (compounding and subsequently filling of syringes and vials), Optical Inspection & Device Assembly Packaging and Warehouse departments at the JSC Schaffhausen site.
The focus for our future colleague will be on processes, equipment and projects in the Parenteral departments. Experience with Compounding processes, Filling processes (isolator technology), Aseptic Process Simulations (APS), Equipment Process Validation (EPV), Smoke studies, Utility processes and Environmental monitoring is key in this role
**Responsibilities**:
- Provide Quality and Compliance guidance to assigned departments and corresponding supporting departments
- Perform Quality and Aseptic oversight on the shop floor
- Qualification of aseptic operators
- Actively contribute to new concepts and projects as well as suggestions for improvement in assigned departments
- Proactive risk mitigation
- Assess and approve Non-Conformances, CAPA investigations, and Corrections/ CAPAs related to utilities, facility, environment and equipment. Quality investigation lead for major Non-Conformances (CAPA investigations)
- Review and approve Protocols, Reports, SOPs/WIs, Change requests (COCs) and other applicable documents
- Review and approve GMP critical SAP master data (e.g. manufacturing instructions)
- Support ‚customers‘ (Production, Quality Control, Logistics, MSAT, Engineering, etc.) in terms of GMP Compliance
- Participate as Subject Matter Expert in Health Authority inspections and audits
**Qualifications**:
Who are you
- You have a Bachelor or Master’s Degree in a microbiological, technical or science field
- You have proven experience (minimum 3 yrs) in a GMP regulated aseptic Pharma production environment, or experience in a relevant Quality role (minimum 2 yrs)
- You demonstrate strong technical and process background in parenteral fill/ finish production
- Exceptional knowledge in aseptic processing is key in this role
- You have experience as team or project lead
- You are fluent in German and English
If you are a team-oriented, open-minded dynamic and highly motivated person with strong interpersonal skills you might be the one we are looking for. For collaboration with different departments, you will need flexibility, social competence, and a reasonable degree of authority. You will take decisions independently and provide advice as needed.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong
-
Local Quality Owner
vor 1 Monat
Schaffhausen, Schweiz Johnson & Johnson VollzeitFür die Welt sorgenbeim Einzelnen beginnen. Dieser Leitsatz inspiriert und eint die Menschen bei Johnson & Johnson. Die Kultur der Fürsorge steht im Mittelpunkt unserer Unternehmensphilosophie, welche im Credo verankert ist. Johnson & Johnson is auf der Suche nach einem Local Quality Owner (M/F/d) für unser Team in Schaffhausen, Schweiz. IHRE AUFGABEN...
-
Junior Area Quality Owner
Vor 4 Tagen
Schaffhausen, Schweiz Johnson & Johnson VollzeitWe manufacture high quality pharmaceutical products and active pharmaceutical ingredients (APIs). Today Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all the major global markets. The Schaffhausen facility is a Johnson & Johnson strategic launch and growth site for parenteral products, and we have an impressive pipeline...
-
2X Junior Area Quality Owner
Vor 4 Tagen
Schaffhausen, Schweiz Johnson & Johnson VollzeitWe manufacture high quality pharmaceutical products and active pharmaceutical ingredients (APIs). Today Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all the major global markets. The Schaffhausen facility is a Johnson & Johnson strategic launch and growth site for parenteral products, and we have an impressive pipeline...
-
Sr. Manager, Product Quality Owner
vor 1 Woche
Schaffhausen, Schweiz Johnson & Johnson VollzeitJanssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting **for a **Sr. Manager, Product Quality Management, Quality Owner.**: The position should be based at the following sites: - Beerse, Belgium, - Leiden, The Netherlands, - Cork, Ireland - Malvern, Springhouse, Chesterbrook, USA - Schaffhausen in Switzerland. At the...
-
Junior Local Quality Owner I
Vor 4 Tagen
Schaffhausen, Schweiz Johnson & Johnson VollzeitWe manufacture high quality pharmaceutical drug products (Small and Large Molecules) and active pharmaceutical ingredients (APIs). Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all major global markets. The Schaffhausen facility is a center for launching and boosting growth in parenterals, having an impressive pipeline...
-
Technical Product Owner
vor 2 Monaten
Schaffhausen, Schweiz Ascent Health Services Switzerland Vollzeit**JOB SUMMARY**: We are looking for a motivated and experienced **Technical Product Owner** to join our team. In this role, you will drive the development and implementation of our digital products, ensuring alignment with business goals and technological excellence. You will work closely with cross-functional teams to deliver impactful solutions that meet...
-
Trainee QA Parenteral Products
vor 3 Wochen
Schaffhausen, Schweiz Johnson & Johnson VollzeitTrainee QA Parenteral Products Hauptaufgaben - Beurteilung und Freigabe von Q-relevanten Stammdaten, Herstellvorschriften und Prozessanpassungen - Projektarbeit zur Optimierung von Arbeitsabläufen innerhalb der Beurteilung und Freigabe von Stammdaten, Herstellvorschriften und Prozessanpassungen - Allgemeine administrative Unterstützung der Local Quality...
-
Reliability Business Process Owner
Vor 4 Tagen
Schaffhausen, Schweiz Johnson & Johnson Vollzeit**Role: Large Molecule Make Asset Management Platform Reliability Business Process Owner**: **Reports to**:Platform Engineer, MAM Strategy, Governance and Performance **Travel**: This position will require up to 20% domestic and international travel. **Location**: Schaffhausen, Switzerland; Cork, Ireland; Leiden, Netherlands, Malvern, USA; Gurabo, Puerto...
-
Planning Manager Dap
Vor 3 Tagen
Schaffhausen, Schweiz Johnson & Johnson Vollzeit**Objectives and Responsibilities**: Manages, Develops, and owns work processes that integrate customer delivery requirements into manufacturing plans. Owns the production schedules for the Device Assembly and Packaging area, supervising a team of detailed schedulers, who proactively address sophisticated trade-offs to successful allocate materials and...
-
Master Production Planner
Vor 3 Tagen
Schaffhausen, Schweiz Johnson & Johnson Vollzeit**Objectives and Responsibilities**: - Accountable for local E2E product flow and performance in alignment with Global Functions (EPLs, VSL’s, CAC’s) and local Quality Product Owner - Point of Contact with Customer Management/Demand management and other stakeholders as required - Continuous improvement of processes to reach the targets - Responsible for...
-
Quality Manager
Vor 2 Tagen
Kanton Schaffhausen, Schweiz Georg Fischer Vollzeit**Your tasks**: - Maintain and further develop our global integrated management system - Review the implementation and effectiveness of the management system - Continuous improvement of our management system - Ensure that the management system complies with ISO 9001, ISO 14001, ISO 45001 and further relevant standards - Continue global rollout of the...
-
Planning Manager Manufacturing
Vor 3 Tagen
Schaffhausen, Schweiz Johnson & Johnson Vollzeit**Objectives and Responsibilities**: Manages, Develops and owns work processes that integrate downstream requirements from the Fill and Finish plan into feasible manufacturing plans, including correct propagation of requirements to the upstream supply chain. Supervise the planning and preparation of rough-cut capacity planning and production schedules for...
-
Schaffhausen, Schweiz Randstad Inhouse Services VollzeitKey Responsibilities: Planning, coordination, and timely execution of the AIQ periodic review, coordinating necessary activities with the QC laboratories. Leading the roll-out of the new HELPr tool in close collaboration with the global ELM CoE Presentation of the AIQ periodic review process during regulatory inspections and customer audits. Creation...
-
Director Schaffhausen Mes Deployment
vor 2 Monaten
Schaffhausen, Schweiz Johnson & Johnson VollzeitJohnson & Johnson is currently seeking a Schaffhausen Manufacturing Execution System (MES) Project Lead to join our team located in Schaffhausen, Switzerland. ROLE: - Lead & deliver MES Project for Schaffhausen site - Primary contact between project team, sponsor and steering committee - Ensure project team representation is aligned with project objectives...
-
Technical Specialist for Laboratory Operations
Vor 2 Tagen
Schaffhausen, Schaffhausen, Schweiz Randstad Inhouse Services VollzeitJob DescriptionWe are seeking a highly skilled Technical Specialist to join our team at Randstad Inhouse Services. As a key member of our laboratory operations, you will play a crucial role in ensuring the smooth execution of our AIQ periodic review process.Key ResponsibilitiesProcess Coordination: Coordinate the planning, organization, and timely execution...
-
Associated Director F2p2 Operations
vor 4 Monaten
Schaffhausen, Schweiz Johnson & Johnson VollzeitJanssen Research and Development, LLC, a member of the Johnson and Johnson Family of Companies, develops treatments that improve the health and lifestyle of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic...
-
Sr. Scientist Biologics Ad
vor 1 Monat
Schaffhausen, Schweiz Johnson & Johnson VollzeitThe Device Methods Laboratory (DML) is a unique group within Johnson and Johnson Innovative Medicine responsible for the end-to-end development and testing of combination products, primary containers, and secondary packaging. Our wide range of responsibilities spans across early and late stages of clinical development, support of technology transfers as well...
-
Intern Operational Excellence Support Assistant
vor 7 Monaten
Kanton Schaffhausen, Schweiz Georg Fischer Rohrleitungssysteme AG VollzeitAt GF, we see our company as a forward-thinking leader in our field. Since 1802, we have been embracing innovations and sustainable solutions of the highest quality that add value to people’s lives around the globe. We offer a full time or part time (50%) position as Operation Excellence (OPEX) Intern for the duration of 6 to 12 months within our agile...
-
Schaffhausen, Schaffhausen, Schweiz Georg Fischer AG VollzeitWe are seeking an experienced IT HCM Application Manager to lead the data migration related to our Workday HCM implementation. The role will focus on managing and migrating data from legacy systems to the new Workday solutions, including the conversion and integration of data into the new HCM data model.ResponsibilitiesManage, plan, coordinate and supervise...
-
Enterprise Data Migration Lead
vor 3 Stunden
Schaffhausen, Schaffhausen, Schweiz Georg Fischer AG VollzeitJob Title: Enterprise Data Migration LeadAbout Us:Georg Fischer AG is a leading provider of high-quality products and solutions for the global market. Our commitment to sustainability and innovation drives us to continuously improve our services.Job Summary:We are seeking an experienced IT Application Manager to lead and manage data migration related to our...