QA Specialist in biopharma multinational
Auf einen Blick
- Veröffentlicht:03 Dezember 2024
- Pensum:100%
- Vertrag:Festanstellung
- Arbeitsort:Upper Valais
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: Write an email.
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: Write an email.
By applying for this position, I consent to the Swisslinx Group of companies:
- storing my personal information (including name, contact details, Identification and CV information etc.) on their internal or external servers for the purpose of informing me of potential employment opportunities
- using my personal information or
- supplying it to third parties upon express consent for the purpose of informing me of potential job opportunities
- transferring where applicable my personal information to a country outside the EEA/EFTA
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