Quality Risks Seen from the Factory Floor

Q1. To begin, could you briefly describe your career history and how your work across quality control, quality assurance, and corporate QA roles has evolved over time?

From my experience, my career has developed step by step acrossQuality Control, Quality Assurance, and Corporate QA, mainly withinpharmaceutical and regulated environments.

InQC, my focus was very much on workingin line with pharma guidelines and regulated markets, ensuring day to day testing, compliance, and data correctness. This is where I acquired a deep understanding in understanding how laboratory results directly impact product release and patient safety.

When I moved intoQA, the scope widened significantly. I became responsible forcontrol over all factory processes, making sure there wasdocumented evidence for every activity,fully aligned withGMP guidelines, ICH, USFDA, EU,and other global regulatory expectations. This included reviewing batch records, managing deviations, handling change control, and making sure that systems were not merely compliant on paper but defensible during inspections.

In myCorporate QArole, my responsibility became more oversight driven and risk focused. I was expected to keep a close eye onin process metrics throughout production, QC, QA, PPIC, stores, and…