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16407en
- Contract
- English, German
- Mid-Senior level
- Legal, Regulatory & Compliance
- Switzerland
- Healthcare & Life Sciences
Skills
ISO / cGMP compliance, QA, Quality Assurance, Change controls, CAPA, OOS, deviations, pharmaceutical, drug substance, aseptic processing, cell therapy
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On behalf of our client, a leading international biotechnology company based in Visp, Swisslinx is looking for a QA Specialist. In this role, you will play a critical part in ensuring GMP compliance and maintaining quality standards by providing hands-on support to operations, managing audits and investigations, and collaborating with teams and clients to drive excellence in quality assurance.
Contract type - Contract
Start Date - January
Location - Visp
Workload - 100%
Duration - 6 months
Your Mission
• Ensure compliance with ISO/cGMP quality system requirements and guidelines, including PICS and EU GMP regulations (Annex 1).
• Provide immediate QA support to operations and quality control teams, addressing compliance concerns on the floor.
• Make quality-related decisions and provide independent QA support to project teams.
• Oversee and audit internal quality systems, external suppliers, vendors, and off-site facilities.
• Manage compliance of Change Controls, CAPAs, investigations, OOS, and deviations.
• Act as a client interface during audits and communications, review and approve validation documents, and support batch review/release activities.
• Lead and prioritize QA projects while managing and directing the work of others when necessary.
Your Background
• 3–5 years of direct QA experience in commercial drug substance/drug product or aseptic processing and cell therapy manufacturing.
• Strong knowledge of GMP compliance, Part 11 compliance, and international aseptic processing regulations.
• Proficient in written and oral communication, legible documentation, and collaboration in fast-paced, team-oriented environments.
• Skilled in Microsoft Office, database management, organization, record-keeping, and handling multiple projects simultaneously.
• Ability to interface and communicate effectively with clients.
What's on offer
• A 6 month contract.
• A great opportunity to develop your career at a leading international biotechnology company.
• A competitive salary.
If this sounds like you, don’t hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter: hugo.palejowski@swisslinx.com.
Contract type - Contract
Start Date - January
Location - Visp
Workload - 100%
Duration - 6 months
Your Mission
• Ensure compliance with ISO/cGMP quality system requirements and guidelines, including PICS and EU GMP regulations (Annex 1).
• Provide immediate QA support to operations and quality control teams, addressing compliance concerns on the floor.
• Make quality-related decisions and provide independent QA support to project teams.
• Oversee and audit internal quality systems, external suppliers, vendors, and off-site facilities.
• Manage compliance of Change Controls, CAPAs, investigations, OOS, and deviations.
• Act as a client interface during audits and communications, review and approve validation documents, and support batch review/release activities.
• Lead and prioritize QA projects while managing and directing the work of others when necessary.
Your Background
• 3–5 years of direct QA experience in commercial drug substance/drug product or aseptic processing and cell therapy manufacturing.
• Strong knowledge of GMP compliance, Part 11 compliance, and international aseptic processing regulations.
• Proficient in written and oral communication, legible documentation, and collaboration in fast-paced, team-oriented environments.
• Skilled in Microsoft Office, database management, organization, record-keeping, and handling multiple projects simultaneously.
• Ability to interface and communicate effectively with clients.
What's on offer
• A 6 month contract.
• A great opportunity to develop your career at a leading international biotechnology company.
• A competitive salary.
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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