Batch Record Reviewer

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Batch Record Reviewer Starting Date: AsapDuration: 3 months with possible extension for another 3 monthsLocation: 100% onsite Language: German proficient, English good command Key responsibilitiesReview of the Executed Batch Records (e.g. cleaning logs, production documentation review, temperature reports, test procedures, raw data, logbooks)Support batch release by ensuring the completeness of the documentation packageReview comments added to the Executed Batch Records, clarify with the operations team and evaluate with the responsible QA ManagerSupport the initiation of deviations and investigations for Batch Record review related observationsCollect and evaluate on a regular basis KPI dataWrite and revise SOPs in his/her area of expertise Key requirementsBachelor degree or equivalentPrevious experience in GDP and GMP regulated pharmaceutical / API industry is an advantageAbility to identify non-compliance and gaps from quality standardsStructured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated German native/very proficient and English good command are requiredSthree Switzerland is acting as an Employment Business in relation to this vacancy.