Batch Records Reviewer 100%

vor 1 Woche


Visp, Schweiz Careforce Vollzeit

Key Responsibilities Review electronic and paper batch records for multiple projects in a timely manner Investigate red flags and comments in batch records (e.g., failed process parameters, material consumption issues, operator notes) using relevant process/data systems and cross-department collaboration Assess and clarify the accuracy of comments and actions on batch records, adding supplementary notes as needed in accordance with GMP, Good Documentation Practices, and ALCOA+ principles Collaborate with BRR team and cross-functional teams to resolve batch record issues and evaluate quality impact statements per GMP and ALCOA+ standards Utilize MES Syncade, DeltaV, Trackwise, SAP, LIMS, DMS, and related systems to investigate batch record issues Perform additional BRR tasks such as Post-Production Lifecycle Document authoring and data cleaning for reports



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