\\nAbout our client:

For our client, a world-leading life sciences company located in the South of Switzerland, Swisslinx is looking for an experienced Senior QA Specialist to representing all QA concerns to the Quality Control (QC) department. This opportunity is open on an initial 6 months contract basis with a possible extension thereafter.

Your responsibilities:

- Representing the QA concerns to the Quality Control (QC) department and ensuring that GMP requirements are met, as well as SOPs are followed
- Controlling and releasing GMP relevant documents of the QC review as well as approval of SOPs, analytical test methods, method transfer protocols, method validation reports and OOx iLab investigations issued by the QC/AD departments
- QA supervision for OOXs events during investigation in QC/AD: Reviewing and approving Out-of-Specifications/-Expectations/-Trend results
- Revising SOPs in area of expertise and ownership of these documents
- Ensuring compliance with GMP in the areas of stability testing and reference standards
- Cooperating, reviewing and approval of deviations (DRs), Investigations (INV), changes (CRs) and CAPAs within analytics (QC)
- Supporting QA for QC raw data review as well as release of LIMS calculation in DMS

Your background:

- Significant experience in the pharmaceutical industry; preferably in a QC or QA function
- Strong analytical expertise and experience with analytical method validation
- Strong background in cGMP regulations including USP, European and Japanese Pharmacopoeia
- Auditing experience and experienced in the interaction with health authorities (FDA, Swissmedic, etc.)
- Bachelor or Master degree in chemistry, biotechnology, life science or related field
- Fluency in English, German is a plus

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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