• Support manufacturing readiness activities, including quality planning, risk assessments, validation activities, digital assurance/CSV/CSA deliverables where applicable, control strategy execution and launch/post-launch learning.
• Apply established Manufacturing QA standards, methods, playbooks and tools to support consistency, standardisation and adoption of proven approaches across manufacturing teams.
• Use quality and manufacturing data, including NCP/CAPA learning, validation outputs, audit findings and process performance signals, to identify trends, support investigations, recommend preventive actions and contribute learning to future Quality Engineering solutions....
Documentation & ReportingRecord inspection results, defect rates, and quality data accurately.Prepare daily/weekly QC reports for management review.Maintain traceability records (batch numbers, inspection logs, etc.).
Non-Conformance HandlingIdentify, isolate, and label defective products.Investigate root causes of quality issues together with production team.Assist in implementing corrective and preventive actions (CAPA).
Compliance & StandardsEnsure production processes comply with relevant industry standards (e.g., ISO 9001) and customer requirements.Support internal and external audits....