\\nAbout our client:

For our client, a world-leading life sciences company located in the South of Switzerland, Swisslinx is looking for an experienced QA Specialist / Batch Record Review to verify the company\\\'s compliance related concerns. This opportunity is open on an initial contract until the EOY2023 with a possible extension thereafter.

Your responsibilities:

- Verification of the company\\\'s compliance with ISO/cGMP quality system requirements
- Providing support to operations and quality control staff to address compliance related concerns (QA on-the-floor support)
- Performing independent quality-related decisions based on regulatory and compliance knowledge by providing independent quality support to project teams
- Auditing of internal quality system elements in manufacturing and operational support areas
- Providing oversight for compliance of Change Controls, CA/PA and investigations, OOS and deviations
- Managing special projects or QA compliance functions as agreed upon with QA management including the prioritization of a variety of projects simultaneously
- Reviewing and approving validation documents such as Master Batch Records (MBR) and supporting documents as well as reviewing/releasing of batch records

Your background:

- 3+ years of direct QA commercial drug substance/drug product experience or an equivalent amount of aseptic processing and cell therapy manufacturing experience
- Familiarity with GMP compliance and Part 11 compliance is a plus
- Experience with oversight of aseptic processing and the associated international aseptic processing regulations
- Excellent written and oral communication to include accurate and legible documentation
- Microsoft Office and database management skills, record keeping skills and ability to handle multiple projects
- Ability to work in a fast-paced environment with great team orientation and independent work skills with a strong work ethic
- Fluency in English

If you are a highly motivated professional looking for an exciting new project within a highly innovative work environment, please apply via the portal or via the Swisslinx website www.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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