QA validation senior specialist

Vor 6 Tagen

Valais, Schweiz BioTalent Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

A key client of BioTalent are looking to onboard a QA senior validation specialist role on a permanent full time basis.

Responsibilities include:

  • Support the validation specialists during the whole lifetime of the cleaning validation to ensure compliance with company procedures and regulatory guidance
  • QA Review and approval of validation documents (Soil characterization studies, risk assessments/ validation protocols and reports).
  • Support Cleaning Development teams during the development phase. Review and approve Cleaning strategy paper, Swab position assessments etc
  • QA Review and approval of Annual cleaning review reports
  • Ensure the validation procedures are consistently implemented
  • Participation in audits and inspections

You will have:

  • Significant experience in the area of biopharmaceutical manufacturing, preferably in a validation function as well as strong background in cGMP
  • Broad knowledge of manufacturing processes in GMP environment
  • Experience in interacting with all kind of interfaces within the organization as well as with regulatory agencies (Swissmedic, FDA etc.)
  • Fluency in English language required, good German language skills would be an advantage
  • Bioprocess experience is a must

Reach out directly to for further information.

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