\\n On behalf of our client, an international pharmaceutical company based in Switzerland, Swisslinx is looking for a QA Specialist for Batch Record Review. This is a contract initially for 3 months (extension is highly possible) starting in September with a great opportunity to bring your proven knowledge and expertise to an organization that offers a dynamic working environment.

- Start date: As soon as possible (September)
- Duration: 3 months
- Extension: highly possible
- Location: Valais
- Workload: 100%

Your mission:

- Verification of the company\\\'s compliance with ISO/cGMP quality system requirements.
- Provide immediate support to operations and quality control staff to address compliance related concerns (QA on-the-floor support).
- Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to 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.
- Independently identify and manage special projects or QA compliance functions as agreed upon with QA management. Prioritize and manage a variety of projects simultaneously.
- Review and approve validation documents. Review and Master Batch Records (MBR) and supporting documents. Perform review/release of batch records, as needed.

Your profile:

- 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.
- 1-3 Years of similar Experience

For further information or to apply please do not hesitate to contact Alina Peeva, Senior Recruiter: alina.peeva@swisslinx.com
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

I also hereby agree to the Swisslinx privacy policy (http://www.swisslinx.com/en/legal/privacy-policy) and Terms of Use (http://www.swisslinx.com/en/legal/disclaimer)\\n \\n \\n \\n \\n \\n

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