BioTalent

QA validation senior specialist

Posted: 1 minutes ago

Job Description

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 guidanceQA 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 etcQA Review and approval of Annual cleaning review reports Ensure the validation procedures are consistently implemented Participation in audits and inspectionsYou will have:Significant experience in the area of biopharmaceutical manufacturing, preferably in a validation function as well as strong background in cGMPBroad knowledge of manufacturing processes in GMP environmentExperience 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 advantageBioprocess experience is a mustReach out directly to luisa.namadila@biotalent.com for further information.

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