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QA Manager – Cleaning Validation
Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a QA Manager – Cleaning Validation for a 6-month contract (with possible extension) based in the Valais area, Switzerland.
- Ensure QA oversight for Cleaning Design activities to a Large-Scale Cell Culture Mammalian Facility
- Define and review CIP strategy approach with the design and CQV team according to company’s procedure and in compliance with regulatory guidance
- Technical lead of cleaning validation teams including communication with customers, as appropriate
- Support / review / approve QC cleaning studies
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required
- Bachelor, master’s degree or PhD in Analytical Science, biotechnology, chemistry or related field
- Significant experience in the GMP regulated pharmaceutical industry; preferable in a role within the Quality Unit (QA, QC)
- Capex project experience (greenfield project would be an advantage)
- Strong background in cGMP
- Broad knowledge in cleaning validation of biopharmaceuticals & Biologics
- Experience in interaction with all kinds of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.)
- Fluency in English, German would be an advantage
Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.