Aktuelle Jobs im Zusammenhang mit Senior Quality Control Analyst - BrotPlamboz NE - WuXi AppTec
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Senior Manager, Quality Projects
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Les Verrières NE, Schweiz WuXi AppTec VollzeitThis position is responsible to support the entire Couvet site to ensure that each product is continuously manufactured, packaged, and tested in compliance with the Marketing Authorisation Dossier managed by the Customer/Product Owner and also to support the site in the Company Regulatory Surveillance initiatives.. As a member of the Quality Leadership...
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Colombier NE, Neuenburg, Schweiz WuXi AppTec VollzeitJob SummaryThis position is a safeguard and role model for the Wu Xi values and competencies. As a key member of the Quality Leadership Team, you will play a critical role in ensuring the quality and compliance of our products and processes.The successful candidate will have a strong understanding of cGMPs and regulatory requirements, as well as experience...
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Colombier NE, Neuenburg, Schweiz WuXi AppTec VollzeitJob SummaryThis position is a safeguard and role model for the Wu Xi values and competencies. As a key member of the Quality Leadership Team, the successful candidate will be responsible for ensuring the entire Couvet site operates in compliance with regulatory requirements and company policies.The position holder will act as the deputy of the Responsible...
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Colombier NE, Neuenburg, Schweiz WuXi AppTec VollzeitJob SummaryThis position is a safeguard and role model for the Wu Xi values and competencies. As a key member of the Quality Leadership Team, the successful candidate will be responsible for ensuring the entire Couvet site operates in compliance with regulatory requirements and company policies.The position holder will act as the deputy of the Responsible...
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Colombier NE, Neuenburg, Schweiz WuXi AppTec VollzeitJob SummaryThis position is a safeguard and role model for the Wu Xi values and competencies. As a key member of the Quality Leadership Team, the successful candidate will be responsible for ensuring the entire Couvet site operates in compliance with regulatory requirements and company policies.The position holder will act as the deputy of the Responsible...
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Colombier NE, Neuenburg, Schweiz WuXi AppTec VollzeitJob SummaryThis position is a safeguard and role model for the Wu Xi values and competencies. As a key member of the Quality Leadership Team, the successful candidate will be responsible for ensuring the entire Couvet site operates in compliance with regulatory requirements and company policies.The position holder will act as the deputy of the Responsible...
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Colombier NE, Neuenburg, Schweiz WuXi AppTec VollzeitJob SummaryThis position is a safeguard and role model for the Wu Xi values and competencies. As a key member of the Quality Leadership Team, the successful candidate will be responsible for ensuring the entire Couvet site operates in compliance with regulatory requirements and company policies.Key ResponsibilitiesAct as the deputy of the Responsible Person...
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Colombier NE, Neuenburg, Schweiz WuXi AppTec VollzeitJob SummaryThis position is a safeguard and role model for the Wu Xi values and competencies. As a key member of the Quality Leadership Team, the successful candidate will be responsible for ensuring the entire Couvet site operates in compliance with regulatory requirements and company policies.Key ResponsibilitiesAct as the deputy of the Responsible Person...
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Colombier NE, Neuenburg, Schweiz WuXi AppTec VollzeitJob SummaryThis position is a safeguard and role model for the Wu Xi values and competencies. As a key member of the Quality Leadership Team, the successful candidate will be responsible for ensuring the proper support of the GMP stakeholder regarding the Product's Dossier and the Regulatory Surveillance.The position holder will collaborate with the other...
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Colombier NE, Neuenburg, Schweiz WuXi AppTec VollzeitJob SummaryThis position is a safeguard and role model for the Wu Xi values and competencies. As a key member of the Quality Leadership Team, the successful candidate will be responsible for ensuring the entire Couvet site operates in compliance with regulatory requirements and company policies.The position holder will act as the deputy of the Responsible...
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Colombier NE, Neuenburg, Schweiz WuXi AppTec VollzeitJob SummaryThis position is a safeguard and role model for the Wu Xi values and competencies. As a key member of the Quality Leadership Team, the successful candidate will be responsible for ensuring the proper support of the GMP stakeholder regarding the Product's Dossier and the Regulatory Surveillance.Key ResponsibilitiesAct as the deputy of the...
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Quality Assurance Expert
Vor 6 Tagen
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Senior Manager QA/RA Projects Lead
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Senior Manager Qa/ra Projects.
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La Brévine Ne, Schweiz WuXi AppTec VollzeitThis position is a safeguard and role model for the Wu Xi values and competencies. Job Summary: This position is responsible to support the entire Couvet site to ensure that each product is continuously manufactured, packaged, and tested in compliance with the Marketing Authorisation Dossier managed by the Customer/Product Owner and also to support the...
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Quality On The Shopfloor Associate
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Neuenburg, NE, Schweiz Takeda Pharmaceutical Vollzeit**À propos du poste**: Le département Qualité de Takeda Neuchâtel est à la recherche d'un(e) **Quality Assurance on the shopfloor Associate** très motivé(e) pour rejoindre l'équipe dédiée à la supervision des activités Qualité sur le terrain pour les secteurs de production de Substance pharmaceutique (**Bulk Drug Substance)** et Remplissage...
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Senior Manager QA/RA Projects Lead
Vor 4 Tagen
La Brévine NE, Schweiz WuXi AppTec VollzeitJob SummaryThis position is a safeguard and role model for the WuXi values and competencies, ensuring the highest standards of quality and regulatory compliance.Key ResponsibilitiesAct as the deputy of the Responsible Person (RP) according to Art. 5, and Art. 17 of the Swiss Ordinance on Establishment Licenses (SR and of the Qualified Person according to...
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Senior Manager QA/RA Projects.
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La Sagne NE, Schweiz WuXi AppTec VollzeitThis position is a safeguard and role model for the WuXi values and competencies. Job Summary: This position is responsible to support the entire Couvet site to ensure that each product is continuously manufactured, packaged, and tested in compliance with the Marketing Authorisation Dossier managed by the Customer/Product Owner and also to support the...
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Senior Manager QA/RA Projects Lead
Vor 4 Tagen
La Brévine NE, Schweiz WuXi AppTec VollzeitJob SummaryThis position is a safeguard and role model for the WuXi values and competencies, ensuring the entire Couvet site adheres to regulatory requirements and maintains high-quality standards.Key ResponsibilitiesAct as the deputy of the Responsible Person (RP) according to Art. 5 and Art. 17 of the Swiss Ordinance on Establishment Licenses (SR) and the...
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Senior Manager QA/RA Projects Lead
Vor 4 Tagen
La Brévine NE, Schweiz WuXi AppTec VollzeitJob SummaryThis position is a safeguard and role model for the WuXi values and competencies, ensuring the entire Couvet site adheres to regulatory requirements and maintains high-quality standards.Key ResponsibilitiesAct as the deputy of the Responsible Person (RP) according to Art. 5 and Art. 17 of the Swiss Ordinance on Establishment Licenses (SR) and the...
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Senior Manager QA/RA Projects Lead
Vor 4 Tagen
La Brévine NE, Schweiz WuXi AppTec VollzeitJob SummaryThis position is a safeguard and role model for the WuXi values and competencies, ensuring the entire Couvet site adheres to the Marketing Authorisation Dossier managed by the Customer/Product Owner and supports the site in Company Regulatory Surveillance initiatives.Key ResponsibilitiesAct as the deputy of the Responsible Person (RP) according to...
Senior Quality Control Analyst
vor 4 Monaten
Job Summary:
This position is responsible to perform all Super User activities for the laboratory computerized systems. This includes at least Audit Trail Reviews and Master Data Management, optimization and/or new method setup, in adherence with data integrity principles as well as end user training, on-the-job training and equipment troubleshooting.
Additional responsibilities are selection, acquisition, and qualification of new analytical equipment by handling, writing and executing Change Control, User Requirement Specification and Performance Qualification protocol. Owns deviations, leads or supports laboratory investigations associated with equipment issues.
As a QC Team Member, the person filling this position supports all activities to continuously maintain the GMP status of the QC Laboratory.
As a Senior QC Team Member this position acts as a centre of competence reflecting experience, transferring knowledge and supporting other QC team members in all aspects of their daily work.
****This a Long-Term Temporary Position****
Essential Job Functions:
- Super User of Laboratory computerized systems.
- Performs Audit trail review.
- Manages Master data for Laboratory software (e.g. Empower, Dissolution Workstation, Tiamo, etc.).
- Assures adherence to data integrity principles.
- Uses technical expertise to investigate and resolve technical issues in the laboratory
- Takes responsibility in selection, purchase and commissioning of new equipment
- Owns the change control, deviation and CAPA, leads or supports risk assessments
- Evaluates impact of compendial changes on applicable QC procedures and opens change controls as required
- Writes and reviews all types of GMP documents (e.g. SOP, TWI, URS, PQ, test method, validation protocols and reports, investigation reports etc).
- Supports internal and external audits
- QC representative in transversal project
- Maintains the GMP status of the laboratory
- In charge of the support of QC team members (“centre of competencies”)
- · Supports maintenance/calibration of equipment and keeps relationship with suppliers
- · Can be assigned special duties and tasks
Experience / Education
- Federal Certificate of Capacity as Laboratory Technician or similar education
- Minimum 5 years of work experience in a GMP environment
Knowledge / Skills / Abilities:
- Excellent knowledge in HPLC and GC techniques and CDS.
- Excellent knowledge of dissolution, UV/VIS and IR techniques.
- Knowledge of analytical method transfer and analytical method validation.
- Experience of doing analytical testing according to Ph. Eur. and USP prescriptions.
- Experience in laboratory equipment qualification.
- Very good communication skills.
- Very good writing skills.
- Excellent team spirit.
- Very good knowledge in English and French.
- Very good knowledge of most common office software.
- Good knowledge and/or ability to familiarize themselves quickly with new software and computerized systems (specific instrument software, LIMS).
- Capability for know-how transfer to and training of other QC team members.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
