Fresenius Kabi
BatchRecordsAuditor
“Batch Records Auditor at Fresenius Kabi. Skills: quality standards, regulatory compliance, production records review, non-conforming results evaluation. Conducts analyses and inspections of raw and packaged materials. executes quantitative and qualitative assays”
What You'll Achieve.
ensures adherence to quality standards and regulatory compliance for manufactured products
Industry & Context.
Evaluating non-conforming results and initiating re-sampling, re-testing, and/or hold procedures
What They're Looking For.
Must Have
Conducts analyses and inspections of raw and packaged materials, executes quantitative and qualitative assays, ensures adherence to quality standards and regulatory compliance for manufactured products, Performing analyses, inspection, and tests of raw materials, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance to customer and regulatory requirements, and tolerance specifications for the chemical or physical property, Performing a variety of qualitative tests or qualitative assays on samples to aid in maintenance and certification of test instruments and apparatus to ensure compliance, Performing required inspections, checks, analysis and documentation of studies, Reviewing production records for conformance to procedures, Evaluating non-conforming results and initiating re-sampling, re-testing, and/or hold procedures
What You'll Do.
Conducts analyses and inspections of raw and packaged materials
executes quantitative and qualitative assays
ensures adherence to quality standards and regulatory compliance for manufactured products
and tests of raw materials
quantitative assays on samples
and/or finished products from manufacturing
to ensure quality standards and compliance to customer and regulatory requirements
and tolerance specifications for the chemical or physical property
Performing a variety of qualitative tests or qualitative assays on samples to aid in maintenance and certification of test instruments and apparatus to ensure compliance
Performing required inspections
analysis and documentation of studies
Reviewing production records for conformance to procedures
Evaluating non-conforming results and initiating re-sampling
and/or hold procedures
Applying for this Batch Records Auditor role?
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