Quality Operations Manufacturing Science Qc
Vor 2 Tagen
At CSL Vifor we have established a new organizational model for managing important Contract Manufacturing Organization (CMO) partnerships. In this context, we are offering an exciting opportunity for our Quality Operations External API & Oral Products Department as
**Quality Operations Manufacturing Science QC Support** Manager**:
In this role you will report into the Head of Quality Operations External API & Oral Products. You will be responsible for ensuring product knowledge within CSL Vifor for providing best support for our CMOs and analytical service providers for external manufactured APIs and Finished Drug Products in the oral portfolio. Furthermore, you will be responsible for the following tasks:
- Management of Quality Control / Manufacturing Science and QA activities for CMOs/suppliers of the oral portfolio
- Ensure knowledge management of manufacturing processes, QC-analytical methods, drug products, APIs and raw materials
- Support for regulatory submissions
- Providing overview about Quality Performance of CMOs (CPV) and product related data (e.g. trending in stability studies)
- Support analytical method transfer to external analytical service providers/CMOs
- Support troubleshooting/root cause analysis activities at CMOs/suppliers
- Providing overview on deviations, complaints and follow-up of defined actions for improving Right First Time
- Support KPI Management for evaluation of CMOs/supplier performance
- Performing QC-releases for Oral Products
- Coordination and handling of relevant processes as change controls, deviations, validations in cooperation with other CSL Vifor departments as Supply Chain, Regulatory, Ext. Development, QPs
**Qualification and experience**
- Bachelor / Master Degree in Life Sciences or related industries or working experience in pharmaceutical Industry
- Minimum 3 years overall experience within the pharmaceutical, biotechnology, or medical device industry
- Experience in Quality Control, Manufacturing or Stability Management
- Experience in lean management tools and Operational Excellence
- Experience with software tools for data analysis, e.g. PowerBI, Excel, Minitab
- troubleshooting, problem solving skills
- team player
- Fluent in English and German in an asset
**Preferred Requirements**
- working experience in different cultures
- working experience in Pharmaceutical/Analytical Development
- Audit experience
CSL Behring is committed to provide equal employment opportunity for all.
**About CSL Vifor**:
CSL Vifor aims to become the global leader in iron deficiency and nephrology.
The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.
**We want CSL to reflect the world around us**:
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
**Do work that matters at CSL Vifor**:
-
Quality Operations Manufacturing Science QC
Vor 2 Tagen
St. Gallen, Schweiz CSL VollzeitQuality Operations Manufacturing Science QC Support Manager In this role you will be responsible for ensuring product knowledge within CSL Vifor for providing best support for our CMOs and analytical service providers for external manufactured APIs and Finished Drug Products in the oral portfolio. Furthermore, you will be responsible for the following...
-
Quality Operations Manufacturing Science QC
Vor 2 Tagen
Sankt Gallen, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Quality Operations Manufacturing Science QC, St. GallenClient:CSLLocation:St. GallenJob Category:OtherJob Reference:7d08dab9a66bJob Views:10Posted:21.01.2025Expiry Date:07.03.2025Job Description:Quality Operations Manufacturing Science QC Support ManagerIn this role you will be responsible for ensuring product...
-
QA Manufacturing Science Manager
vor 23 Stunden
St. Gallen, Schweiz Vifor Pharma VollzeitCSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better,...
-
St. Gallen, Schweiz Vifor Pharma Vollzeit-CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead...
-
St. Gallen, Schweiz CSL Behring VollzeitWe are currently looking for a Quality Assurance Manager /Specialist CMO/ Supplier Management Oral Products to join our team in St Gallen. **Main Responsibilities** - Management of CMOs and Suppliers for the oral portfolio. - Processing all quality related tasks for the outsourced manufacturing and services to different contract manufacturing organizations...
-
Graduate Technical Operations
vor 1 Woche
St. Gallen, Schweiz Vifor Pharma VollzeitCSL Vifor is offering you the great opportunity to participate in our 2-year Graduate Program within Technical Operations, Quality (Zurich and St. Gallen). **This exciting program includes the following**: - Assignment in key functions within Technical Operations: Supply Chain Management, Quality Assurance (QA), Technical Project Management - Cooperation...
-
Quality Audit
Vor 2 Tagen
St. Gallen, Schweiz CSL VollzeitTitle: Auditor (Senior), External Supplier Quality Location: St. Gallen, Switzerland (flexible/hybrid work model) Type of role: Permanent position We are looking for a (Senior) Auditor External Supplier Quality to join our Quality team in St. Gallen on a permanent basis. You will support the local site regarding supplier/third-party qualification...
-
Npi QA Manager
vor 1 Woche
St. Gallen, Schweiz Vifor Pharma Vollzeit-CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead...
-
Drone Manufacturing Technician
Vor 5 Tagen
St. Gallen, Schweiz Meteomatics Vollzeit**Drone Manufacturing Technician | Full time | St. Gallen, Switzerland**: **What's the weather like tomorrow? ️** How much energy will my solar power plant generate this week? Is this flight path safe and efficient? Will there be enough rain to water my crops? As the weather affects many industries' performance, businesses keep a close eye on what's...
-
St. Gallen, Sankt Gallen, Schweiz CSL Vifor VollzeitWe are seeking a System Specialist to join our team at CSL Vifor in St. Gallen, Switzerland.Your primary responsibilities will include:Providing support on Good Manufacturing Practices (GMP) processes to ensure compliance with company standards and regulatory guidelines.Developing, maintaining, and improving GMP-related Standard Operating Procedures...
-
Quality Audit
Vor 2 Tagen
Sankt Gallen, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Quality Audit & Supplier Qualification, St. GallenClient:CSLLocation:St. GallenJob Category:OtherJob Reference:f2c9b3c98fc3Job Views:11Posted:22.01.2025Expiry Date:08.03.2025Job Description:Title: Auditor (Senior), External Supplier QualityType of role: Permanent positionWe are looking for a (Senior) Auditor...
-
Sachbearbeiterin Gxp Quality Systems
Vor 5 Tagen
St. Gallen, Schweiz CSL Behring VollzeitZur Verstärkung unseres Qualitätsteams in St. Gallen suchen wir derzeit eine(n) SachbearbeiterIn GxP Quality Systems für einen befristeten Vertrag (12 Monate). In dieser Position berichten Sie direkt an den Leiter des Qualitätsmanagementsystems. Wir bieten ein flexibles und hybrides Arbeitsmodell an. (#LI-Hybrid) **Hauptaufgaben** - Administrative...
-
GMP Quality Assurance Professional
vor 3 Stunden
St. Gallen, Sankt Gallen, Schweiz CSL Vifor VollzeitAbout the RoleWe are looking for a talented professional to join our team as a QA Compliance and System Specialist. In this role, you will play a critical part in ensuring compliance with company standards and regulatory guidelines, developing and maintaining GMP-related standard operating procedures (SOPs), and supporting various quality processes.Your...
-
Quality Audit Management Lead
Vor 6 Tagen
St. Gallen, Schweiz Vifor Pharma Vollzeit-We are currently looking for a Quality Audit Management Lead to join our team in St. Gallen. In this position you will have overall responsibility & accountability for the oversight and management of CSL Vifor GxP Quality Assurance audit programs including GMP, GDP, and Clinical, Medical, Regulatory & Safety (CMRS) aspects in line with existing regulations....
-
Quality Engineer
Vor 2 Tagen
Sankt Gallen, Schweiz TN Switzerland VollzeitIn this role, you will have the opportunity to drive meaningful improvements, collaborate with talented professionals, and contribute to the ongoing success of a global leader in data and energy transmission technologies.Candidate profile:Technical Expertise: In-depth understanding of high-frequency, fiber optic, and low-frequency technologies, including the...
-
Quality Audit Management Lead
vor 1 Woche
St. Gallen, Schweiz CSL Behring VollzeitWe are currently looking for a Quality Audit Management Lead to join our team in St. Gallen. In this position you will have overall responsibility & accountability for the oversight and management of CSL Vifor GxP Quality Assurance audit programs including GMP, GDP, and Clinical, Medical, Regulatory & Safety (CMRS) aspects in line with existing regulations....
-
Controller
Vor 3 Tagen
St. Gallen, Schweiz Evergreen Human Resources VollzeitIn dieser vielseitigen Funktion übernehmen Sie diverse Aufgaben im Business/Operations Controlling sowie der Finanzanalyse im Produktions - und Projektumfeld unseres Kunden (Operations/Div. Standorte/BUs). Es handelt sich um eine vielseitige Funktion in einem kollegialen Controlling/Finance Team in welcher Sie die Chance haben das Controlling gemeinsam mit...
-
Quality Engineering specialist
Vor 3 Tagen
Saint Gallen, Schweiz Pharmiweb VollzeitProclinical is seeking a Quality Engineering Specialist to join our client's team in Visp, Switzerland. This role focuses on managing quality-related responsibilities for daily qualification activities on technical facilities, equipment, and systems. We are looking for someone who can support the development, review, and release of qualification documents,...
-
Customer Operations and Export Coordinator
vor 1 Woche
St. Gallen, Schweiz Vifor Pharma Vollzeit-CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead...
-
Head of Quality
Vor 2 Tagen
Sankt Gallen, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Responsibilities:Management and further development of all areas of quality management with a total of 8 employeesFurther development of the existing quality, safety and environmental management systems in collaboration with managementSupport of internal areas such as operations, research & development and sales...