Product Quality Assurance Senior Officer
Updated: May 09, 2024 03:46 AM GMT
Bayer
Depok, Depok City, West JavaProduct Quality Assurance Senior Officer
YOUR TASKS AND RESPONSIBILITIES
• Perform MBR review in Pas-x for dispensing process, perform review Batch Record, Lab Work Sheet and Batch Report Review in MES Pass-x System for releasing process, and perform archiving batch record.
• Support disposition batches of packing materials, raw materials, imported bulks or products (both physically/its hard copy and the SAP system).
• Perform PQR report on every reporting year (January of following year) by reviewing batch records, reviewing the results of assay testing and critical-in process control parameter, reviewing the process capability index of each result, reviewing complaints, deviations, OOS, Non-conformity, Stability study, changes, process validations report following valid SOP that notified in PQR period review.
• Perform review activities and progress report environmental monitoring and review GMP alarm report.
• Perform Local Risk Assessment Management following Valid SOP.
• Perform... More Detail
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