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16105en
- Contract
- English
- Mid-Senior level
- Engineering & Technical Services
- Switzerland
- Healthcare & Life Sciences
Skills
quality management, regulatory affairs, regulation, GMP, cGMP, quality assurance, QA
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On behalf of our client, a multinational manufacturing company for the pharmaceutical, biotechnology and nutrition sectors, Swisslinx is seeking a Senior Quality Systems Manager.
Start Date - As soon as possible
Location - Visp
Workload - 100%
Duration - 3 months with possible extension
Your mission:
• Verify the company’s compliance with ISO/cGMP quality systems and knowledge of PICS or EU Guidelines to Good Manufacturing Practice, including Annex 1.
• Provide immediate support to operations and quality control staff to address compliance related concerns.
• Make independent quality decisions based on regulatory knowledge and support project teams.
• Audit internal quality system elements in manufacturing and operational support areas.
• Provide oversight for compliance of Change Controls, CA/PA and investigations, OOS and deviations.
• Act as a customer interface during on-site audits, conference calls and other standard means of communication.
• Review and Master Batch Records (MBR) and supporting documents.
• Perform review/release of batch records, as needed.
Your background:
• 5-10 years’ experience required.
• Direct QA commercial drug substance/drug product experience required or an equivalent amount of aseptic processing and cell therapy manufacturing experience.
• GMP compliance and Part 11 compliance knowledge preferred.
• Experience with oversight of aseptic processing and the associated international aseptic processing regulations.
• Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast-paced environment; team oriented; independent work skills and a strong work ethic.
• Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.
What’s an offer?
• Great team & company culture in a leading pharma company & international environment.
• An initially 3 month contract with possible extension.
If this sounds like you, don’t hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter: hugo.palejowski@swisslinx.com
Start Date - As soon as possible
Location - Visp
Workload - 100%
Duration - 3 months with possible extension
Your mission:
• Verify the company’s compliance with ISO/cGMP quality systems and knowledge of PICS or EU Guidelines to Good Manufacturing Practice, including Annex 1.
• Provide immediate support to operations and quality control staff to address compliance related concerns.
• Make independent quality decisions based on regulatory knowledge and support project teams.
• Audit internal quality system elements in manufacturing and operational support areas.
• Provide oversight for compliance of Change Controls, CA/PA and investigations, OOS and deviations.
• Act as a customer interface during on-site audits, conference calls and other standard means of communication.
• Review and Master Batch Records (MBR) and supporting documents.
• Perform review/release of batch records, as needed.
Your background:
• 5-10 years’ experience required.
• Direct QA commercial drug substance/drug product experience required or an equivalent amount of aseptic processing and cell therapy manufacturing experience.
• GMP compliance and Part 11 compliance knowledge preferred.
• Experience with oversight of aseptic processing and the associated international aseptic processing regulations.
• Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast-paced environment; team oriented; independent work skills and a strong work ethic.
• Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.
What’s an offer?
• Great team & company culture in a leading pharma company & international environment.
• An initially 3 month contract with possible extension.
If this sounds like you, don’t hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter: hugo.palejowski@swisslinx.com
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