QA Manager Gmp/gdp
vor 3 Wochen
**Salary**:Competitive
- **REF Number**:00055201
- **Consultant**:Kajenthi Chelliah
- **Contact**:0041 800 106 106
- **Date Published**:03.03.2023
- **Sector**:
- **Location**:Allschwill,
- **Discipline**:
CK QLS are recruiting for a QA Manager GMP GDP to join a Biopharmaceutical Company based in Allschwil (Basel-Land) on a 1 year contract basis.
The company is specialized in the research and development of pharmaceutical, biological, and diagnosticproducts. It offers drugs for the treatment of insomnia, Fabry disease, cerebral vasospasm, resistant hypertension and lupus.
His/Her roles will have to:
- Provide GMP/GDP quality assurance expertise during development and commercialization ofIdorsia’s products
- For assigned projects, provide guidance on the resolution of complaints, testing issues, deviations, discrepancies and Out of Specifications (OOS), investigations and propose Corrective and Preventive Actions (CAPA) as needed
- Manage all required activities to support release of active ingredients, commercial products and/or investigational medicinal products including approval of master process documentation, batch record review and assessment of change controls
- Notify CMC team and management of potential quality, regulatory and lead time issues
- Assist in the conduct of GMP/GDP audits at 3rd party sites when needed
- Write, review, and/or approve internal SOP’s and GMP/GDP related Documentations
- Master in Pharmacy, Chemistry or equivalent
- Previous experience in quality assurance of drug substance and/or drug Product and in pharmaceutical product development/ quality control/ analytical development/ chemical production
- Good knowledge of GMP/GDP
- Efficient and effective verbal and written communication skills in English and German (preferred)
-
QA Inspector
vor 4 Wochen
Allschwil, Schweiz Thermo Fisher Scientific VollzeitThermo Fisher Scientific Inc. ist der weltweit führende Partner für die Wissenschaft mit einem Umsatz von 40 Mrd. USD und mehr als 100.000 Mitarbeitern in 55 Ländern. Unsere Mission ist es, unsere Kunden in die Lage zu versetzen, die Welt gesünder, sauberer und sicherer zu machen. Fisher Clinical Services GmbH ist eine Tochtergesellschaft von Thermo...
-
QA Specialist
vor 4 Wochen
Allschwil, Schweiz Thermo Fisher Scientific Vollzeit: Review of executed batch records, creation of certificate of packaging Support QA Pre-Approval as required by line manager/workload: Review and quality approval of pre-executed batch documentation, finished product with TOE and label components, change orders, packaging and labelling requests, job specifications, packaging orders, LINKS reports,...
-
Procurement Manager Supply Chain
Vor 5 Tagen
Allschwil, Schweiz Basilea Pharmaceutica International Vollzeit**We are looking for...**: ....a highly motivated Procurement Manager Supply Chain & Technical Operation for our Finance department. **Your tasks**: - Manage sourcing activities with a focus on the category Supply Chain ranging from development to commercial pharmaceutical products - Responsible for Strategic Procurement and Vendor Relationship...
-
Quality Assurance Manager
vor 4 Wochen
Allschwil, Schweiz SKAN AG VollzeitResponsibilities Maintaining and further developing the quality management system Quality assurance functions within the SKAN product and project organisation, as well as the international service business and ensuring the associated customer communication Conformity check of internal specification documents, processes, reports and technical...
-
Qualification Manager
vor 3 Wochen
Allschwil, Basel-Land, Schweiz Skan AG VollzeitQualification Manager (m/w/d)1968 gegründet, zählt SKAN zu den Pionierfirmen in den Fachbereichen Reinraumausrüstungen und Entwicklung von Isolatoren für die pharmazeutische Industrie. Innovative Produkte, kundenspezifische Lösungen sowie eine leistungsfähige Dienstleistungs- und Serviceorganisation haben SKAN zu einem Marktführer und wichtigen...
-
Manager Manufacturing
Vor 7 Tagen
Allschwil, Schweiz Thermo Fisher Scientific VollzeitThermo Fisher Scientific Inc. ist mit einem Jahresumsatz von über 40 Milliarden US-Dollar weltweit führend im Dienste der Wissenschaft. Unsere Mission ist es, unsere Kunden in die Lage zu versetzen, die Welt gesünder, sauberer und sicherer zu machen. Ob unsere Kunden die Life-Sciences-Forschung beschleunigen, komplexe analytische Herausforderungen lösen,...
-
Client Services Project Manager I
vor 3 Wochen
Allschwil, Schweiz Thermo Fisher Scientific Vollzeit: Partners with the Client and the internal project management team to help support the success of a study in any way possible. This may include meetings either at Thermo Fisher Scientific sites or at the client’s premises. Assists in setting up and maintaining study filing systems and maintains accurate records for all work undertaken, working with...
-
Projekt Manager Automation
Vor 2 Tagen
Allschwil, Basel-Land, Schweiz Skan AG VollzeitProjekt Manager Automation (m/w/d)1968 gegründet, zählt SKAN zu den Pionierfirmen in den Fachbereichen Reinraumausrüstungen und Entwicklung von Isolatoren für die pharmazeutische Industrie. Innovative Produkte, kundenspezifische Lösungen sowie eine leistungsfähige Dienstleistungs- und Serviceorganisation haben SKAN zu einem Marktführer und wichtigen...
-
Project Manager Bauprojekte 100% m/w/d
Vor 5 Tagen
Allschwil, Basel-Land, Schweiz Adecco VollzeitSie sind hochmotiviert und suchen neue Perspektiven? Dann bewerben Sie sich so schnell wie möglich als:Project Manager Bauprojekte 100% m/w/dIhre HerausforderungProjektleitung für die Realisierung von Anlagen, Gebäuden, Flächen, Systemen und Geräten Koordination und aktives Management von Bauprojekten von der Vorstudie bis zur Endabrechnung Überwachung...
-
Distribution Associate Project Manager
Vor 4 Tagen
Allschwil, Schweiz Thermo Fisher Scientific VollzeitThe **Associate Project Manager **provides support to a Project Manager in handling projects/ studies for customers and in the development of workflow processes between the customer and the business. Specifically, the APM assists the Project Manager in study management across the organization and various departments, proactively working with all the parties...
-
Distribution Associate Project Manager
vor 4 Wochen
Allschwil, Schweiz Thermo Fisher Scientific Vollzeit**Position Summary**: The **Associate Project Manager **provides support to a Project Manager in handling projects/ studies for customers and in the development of workflow processes between the customer and the business. Specifically, the APM assists the Project Manager in study management across the organization and various departments, proactively working...
-
Client Services Project Manager I
vor 3 Wochen
Allschwil, Schweiz Thermo Fisher Scientific Vollzeit: Partners with the Client and the internal team to help support the success of a study in any way possible. This may include meetings either at Thermo Fisher Scientific sites or at the client’s premises. Assists in setting up and maintaining study filing systems and maintains accurate records for all work undertaken, working with appropriate quality...
-
Sales Manager Life Cycle Support 80-100%
vor 3 Wochen
Allschwil, Basel-Land, Schweiz Skan AG VollzeitSales Manager Life Cycle Support 80-100% (w/m/d)1968 gegründet, zählt SKAN zu den Pionierfirmen in den Fachbereichen Reinraumausrüstungen und Entwicklung von Isolatoren für die pharmazeutische Industrie. Innovative Produkte, kundenspezifische Lösungen sowie eine leistungsfähige Dienstleistungs- und Serviceorganisation haben SKAN zu einem Marktführer...
-
P-429800 Client Services Project Manager I
vor 2 Wochen
Allschwil, Schweiz Thermo Fisher Scientific Vollzeit: Partners with the Client and the internal team to help support the success of a study in any way possible. This may include meetings either at Thermo Fisher Scientific sites or at the client’s premises. Assists in setting up and maintaining study filing systems and maintains accurate records for all work undertaken, working with appropriate quality...
-
P-429800 Client Services Project Manager I
vor 1 Woche
Allschwil, Schweiz Thermo Fisher Scientific Vollzeit**Position Summary**: **As a member of Global Client Services, you are part of One Global Distributed Team: Empowered to Act, Make Connections and get results for our customers and their patients.** The Project Support Associate is a key member of our Project Management team and provides pivotal support which enables unparalleled service to our clients....
-
Client Services Project Manager I
Vor 6 Tagen
Allschwil, Schweiz Thermo Fisher Scientific Vollzeit**Position Summary**: **As a member of Global Client Services, you are part of One Global Distributed Team: Empowered to Act, Make Connections and get results for our customers and their patients.** The Project Support Associate is a key member of our Project Management team and provides pivotal support which enables unparalleled service to our clients....
-
Quality Assurance Manager
vor 3 Wochen
Allschwil, Schweiz SKAN AG VollzeitAuf einen BlickFür den Aufbau unseres neuen Bereiches «Aseptic Manufacturing Services» suchen eine erfahrene Persönlichkeit mit Kenntnissen in der Equipment-Qualifizierung und CSV im GxP-Pharmaumfeld. In dieser Funktion sind Sie unter anderem für die Implementierung und Umsetzung der Qualifizierungsstrategie für unsere Prozessequipments verantwortlich....
-
Project Manager Automation
vor 2 Wochen
Allschwil, Schweiz SKAN AG VollzeitResponsibilities Coordination of automation resources in the project organization Single point of contact for the customer and project teams regarding automation topics Review of customer specification documents and ensuring compliance with automation requirements Tracking and reporting of project status and milestones Creation of basic...
-
Qc Technician Ii
vor 4 Wochen
Allschwil, Schweiz Thermo Fisher Scientific VollzeitFisher Scientific Inc. ist der weltweit führende Partner für die Wissenschaft mit einem Umsatz von 20 Mrd. USD und mehr als 70'000 Mitarbeitern in 50 Ländern. Unsere Mission ist es, unsere Kunden in die Lage zu versetzen, die Welt gesünder, sauberer und sicherer zu machen. **In Process Inspector Operations / Mitarbeiter...
-
Project Manager 100%
Vor 4 Tagen
Allschwil, Schweiz SKAN AG VollzeitFounded in 1968, **SKAN** is a pioneer in cleanroom equipment and the development of isolators for the pharmaceutical industry. Innovative products, tailor-made solutions and an effective service organisation have made SKAN a market leader and a key partner to industry and research laboratories. **Responsibilities**: - Global responsibility for several...
