Fresenius Kabi (Schweiz) AG
Junior Quality Manager(m/w/x)
Full-timeWith HomeofficeJunior
Kriens
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MEMerck & Co., Inc.
Quality Assurance Specialist(m/w/x)
Luzern
Full-timeWith Home OfficeExperienced
Nejo AI Summary
LMS administration and Veeva Vault document oversight for biopharmaceutical production. Master's in life sciences and 2 years GMP/GDP QA experience required. Work in a globally integrated biopharma quality system.
Requirements
- Master's Degree in pharmacy, medicine, biology or equivalent
- Two years experience in Quality Assurance (GMP/GDP)
- Knowledge and experience in Learning management
- Experience with GxP regulations (Swiss, European, international)
- Experience with quality or workflow management tools
- Business fluent English and German skills
- Analytical, problem-solving, and risk management skills
- Teamwork, communication and problem-solving skills
Tasks
- Administer the Learning Management System
- Manage training documentation
- Coordinate and monitor general GDP training
- Provide first-line support for the LMS
- Oversee controlled documents in Veeva Vault
- Support markets with Document Management Systems
- Review batch certificates against regulatory requirements
- Record and evaluate transport temperature data
- Process deviations
- Administer pharmaceutical quality assurance systems
- Manage Change Control for GxP-critical areas
- Review and update standard operating procedures
- Implement inputs during document reviews
- Prepare yearly self-inspections for key processes
- Support continuous Quality Management System improvements
- Ensure timely review of Product Quality Reports
- Process and track Product Quality Complaints
- Provide feedback and metrics on quality complaints
- Inform Pharmacovigilance regarding suspected adverse events
Work Experience
- 2 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- Veeva Vault QualityDocs
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Merck & Co., Inc. and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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MEMerck & Co., Inc.
Quality Assurance Specialist(m/w/x)
Luzern
Full-timeWith Home OfficeExperienced
Nejo AI Summary
LMS administration and Veeva Vault document oversight for biopharmaceutical production. Master's in life sciences and 2 years GMP/GDP QA experience required. Work in a globally integrated biopharma quality system.
Requirements
- Master's Degree in pharmacy, medicine, biology or equivalent
- Two years experience in Quality Assurance (GMP/GDP)
- Knowledge and experience in Learning management
- Experience with GxP regulations (Swiss, European, international)
- Experience with quality or workflow management tools
- Business fluent English and German skills
- Analytical, problem-solving, and risk management skills
- Teamwork, communication and problem-solving skills
Tasks
- Administer the Learning Management System
- Manage training documentation
- Coordinate and monitor general GDP training
- Provide first-line support for the LMS
- Oversee controlled documents in Veeva Vault
- Support markets with Document Management Systems
- Review batch certificates against regulatory requirements
- Record and evaluate transport temperature data
- Process deviations
- Administer pharmaceutical quality assurance systems
- Manage Change Control for GxP-critical areas
- Review and update standard operating procedures
- Implement inputs during document reviews
- Prepare yearly self-inspections for key processes
- Support continuous Quality Management System improvements
- Ensure timely review of Product Quality Reports
- Process and track Product Quality Complaints
- Provide feedback and metrics on quality complaints
- Inform Pharmacovigilance regarding suspected adverse events
Work Experience
- 2 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- Veeva Vault QualityDocs
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Merck & Co., Inc. and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Merck & Co., Inc.
Industry
Pharmaceuticals
Description
Das Unternehmen agiert als weltweit zuverlässiger Hersteller und Lieferant von Biopharmazeutika und beliefert Kunden und Patienten mit qualitativ hochwertigen Produkten.
Not a perfect match?
- Fresenius Kabi (Schweiz) AG
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